[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dry-eye-syndrome-des\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dry-eye-syndrome-des":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,70,96,120,143,178],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642261","phase-4-a-multicenter-open-label-study-to-evaluate-perioperative-treatment-of-dry-eye-with-miebo-in-subjects-undergoing-lasik-100642261",false,"NCT07650708","A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK","Sonoran","Inclusion Criteria:\n\n1. Be at least 18 years of age at the time of consent, able to provide written voluntary informed consent, willing to follow instructions and participate in all trial assessments and visits\n2. Be a candidate for routine, uncomplicated bilateral LASIK surgery (for spherical equivalent \\[≤-8.00D\\] myopia or myopic astigmatism correction, not combined with any other procedure; monovision myopic targets are allowed, however the myopic target eye will be the non-study \\[fellow\\] eye)\n3. No history of refractive surgery including implantable Collamer lens (ICL) or cataract surgery\n4. Total CFS score ≥1 and ≤6 using the National Eye Institute scale at Visit 1 (in at least one eye)\n5. Ocular Surface Disease Index (OSDI) ≥13 and ≤22 at Visit 1\n\nExclusion Criteria:\n\n1. Have any clinically significant ocular surface slit-lamp findings in the study eye that, in the opinion of the Investigator, could interfere with outcomes of a routine, uncomplicated LASIK surgery, including but not limited to:\n\n   1. History of eye trauma\u002Fsurgery within the last 6 months that resulted in corneal scarring\n   2. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells, Stevens-Johnson syndrome, active blepharitis, or lid margin inflammation\n   3. Abnormal cornea (e.g., keratoconus or corneal epithelial defect, pterygium, or history of herpetic keratitis)\n2. Use of any of the following ocular therapies in the study eye within 30 days prior to Visit 1: topical ocular steroid treatments, prescription dry eye therapy (including nasal spray), or topical intraocular pressure-lowering medications\n3. Use of any eye drops (prescription or over the counter) in the study eye within 24 hours prior to Visit 1\n4. Use of any oral medications known to cause ocular drying (e.g., antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial\n5. Had a LipiFlow®, intense pulsed light (IPL) therapy, etc. in the study eye within 3 months prior to Visit 1\n6. Had received or removed a permanent punctum plug in the study eye within 1 month (3 months for dissolvable punctum plugs) prior to Visit 1\n7. Have worn soft contact lenses within either 3 days prior to the study or rigid gas-permeable contact lenses for 1 month prior to Visit 1 or any planned wear during the study\n8. Have undergone intraocular surgery or ocular laser surgery in the study eye within 3 months prior to Visit 1\n9. Have ocular allergies that are\u002Fexpected to be active during the trial period\n10. Have active ocular or systemic infection (bacterial, viral, or fungal), including fever\n11. Have any ocular findings or uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial\n12. Female subjects who are pregnant, nursing, or planning a pregnancy\n13. Female subjects of childbearing potential who are not using an acceptable means of birth control; acceptable methods of contraception include hormonal (oral, implantable, injectable, or transdermal) contraception; mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom) contraception; intrauterine device; or surgical sterilization of partner. For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.\n14. Have a known allergy and\u002For sensitivity or lack of desired efficacy in response to the investigational drug\n15. Are currently enrolled in an investigational drug or device study or had used an investigational drug or device within 30 days prior to Visit 1 -","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","Compare eye dryness following laser-assisted in situ keratomileusis (LASIK) surgery to eye dryness prior to receiving perioperative Miebo in patients with dry eye disease (DED)",[26,27],"Dry Eye Syndrome (DES)","Dry Eye Disease (DED)","RECRUITING","2026-06-19",{"date":31,"type":32},"2026-06-24","ACTUAL",{"date":34,"type":32},"2026-05-05",{"date":36,"type":20},"2026-12-01",{"name":38,"class":39},"Vance Thompson Vision","OTHER",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100643673","study-of-proteomic-factors-in-patients-with-severe-dry-eye-syndrome-treated-with-autologous-serum-eye-drops-100643673","NCT07632534","Study of Proteomic Factors in Patients With Severe Dry Eye Syndrome Treated With Autologous Serum Eye Drops.","Study of Proteomic Factors in Patients With Severe Dry Eye Syndrome Treated With Autologous Serum Eye Drops. Single-center Study.","Prot-CSA","Inclusion Criteria:\n\n* Age over 18 years\n* Patients with severe dry eye with an Oxford score \\> 1\n* Patients with dry eye syndrome refractory to conventional treatments: tear substitutes, immunosuppressive eye drops or corticosteroids.\n* AS-naïve patients followed by an ophthalmologist at Saint-Etienne University Hospital\n* Patients affiliated to or entitled under a social security scheme\n* Patients who have received informed information about the study\n\nExclusion Criteria:\n\n* Severe ocular dryness due to a genetic disease\n* Patients not under the care of an ophthalmologist at Saint-Etienne University Hospital.\n* Patients not eligible for treatment with AS (pregnant women, anaemia, current infection, progressive disease, serological results contraindicating blood sampling).\n* Patients under protective measures",{"count":50,"type":20},68,[52],"NA","Dry eye syndrome is a multifactorial pathology of the ocular surface. Epidemiological studies report a prevalence of 15% in adults aged between 50 and 95. Depending on the severity of the disease, different treatment strategies may be proposed. The use of autologous serum eye drops (AS) represents an interesting therapeutic alternative for the most severe forms of the disease, due to the serum's composition, which is similar to that of tears. The mechanism of action of AS is still controversial, but is probably multifactorial and seems to be based on growth factors, vitamin factors and anti-inflammatory factors. The clinical response of patients could be dependent on the protein composition of the eye drops. The investigators are aiming to highlight a difference in serum protein composition that could explain the differences in clinical response between patients treated with autologous serum eye drops and to identify the proteins that would be involved in a clinical response or non-response.",[26,55],"Dry Eye",[57,58],"autologous serum eye drops","dry eye disease","NOT_YET_RECRUITING","2026-06-02",{"date":62,"type":32},"2026-06-08",{"date":64,"type":20},"2026-06",{"date":66,"type":20},"2028-12",{"name":68,"class":39},"Centre Hospitalier Universitaire de Saint Etienne",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":69},"100637235","evaluation-of-a-novel-ocular-lubricating-eye-drop-100637235","NCT07593404","Evaluation of a Novel Ocular Lubricating Eye Drop","DRAGON","Inclusion Criteria:\n\n1. Are at least 18 years of age and have capacity to volunteer\n2. Are able to read (Part 2 only);\n3. Have signed an information and consent letter;\n4. Are willing to follow instructions and maintain the appointment schedule;\n5. Are willing to refrain from contact lens wear throughout the study period;\n6. Have a best corrected visual acuity of +0.20 LogMAR or better in each eye;\n7. Have an OSDI score ≥13 AND at least one of the following signs in at least one eye: Non-invasive tear film break-up time (NITBUT) \\\u003C 10 sec, AND\u002FOR ocular surface staining (\\> 5 corneal spots, and\u002F or \\> 9 conjunctival spots)\n\nExclusion Criteria:\n\n1. Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days;\n2. Have a known active ocular disease and\u002F or infection with the exception of dry eye disease;\n3. Have any slit lamp findings that would contraindicate use of the study product;\n4. Have a systemic condition that would contraindicate use of the study product;\n5. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;\n6. Have undergone refractive error surgery or intraocular surgery within the last 12 months;\n7. Have any known sensitivity or allergy to the diagnostic sodium fluorescein or to any ingredients in the study product;\n8. Are using ocular lubricating eye drops more than twice per day on a typical day over the past month (Part 2 only);\n9. Are an employee of the Centre for Ocular Research \\& Education directly involved in this study",{"count":78,"type":20},40,[52],"The objective of this 2-part study is to assess the safety and tolerability of the new ocular lubricating drop ABR2 during short-term use in subjects for the temporary relief of ocular discomfort due to dryness of the eye.\n\nIn Part 1, participant will receive 1 drop of ABR2 in one eye and through assessments over a 1-hour period.\n\nIn Part 2, participant will use 1 drop of ABR2 at least two times a day for 28-day period (may use up to 4 times a day as needed) This is a single arm, open label study with no placebo or comparative arm.",[26],[83,84,85],"dry eye syndrome","ophthalmic solution","lubrication","2026-05-15",{"date":88,"type":32},"2026-05-19",{"date":90,"type":20},"2026-05",{"date":92,"type":20},"2027-05",{"name":94,"class":95},"Pleryon Therapeutics (Hangzhou) Limited","INDUSTRY",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":69},"100630658","phase-4-this-is-a-single-center-open-label-prospective-study-to-evaluate-the-effect-of-xiidra-lifitegrast-ophthalmic-solution-50-on-tear-film-biomarkers-in-dry-eye-100630658","NCT07490535","This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) on Tear Film Biomarkers in Dry Eye","Single-Center, Open-Label Trial to Evaluate the Effect of Lifitegrast Ophthalmic Solution 5.0% on Tear Film Biomarkers in Dry Eye Disease","Inclusion Criteria: DED Subjects receiving Xiidra®\n\n1. At least 18 years of age or older at time of screening\n2. Ability to understand and provide informed consent\n3. Subject reported 6-month history of DED in both eyes\n4. No use of ophthalmic drops other than lifitegrast within 2 hours of tear fluid collection to minimize interference with baseline biomarker levels\n5. Willingness to comply with follow-up schedule and required visits\n6. Corneal fluorescein staining score of inferior 1\u002F3rd of cornea ≥ 2\n7. EDS ≥40 (0-100-point VAS, both eyes) at Day 0\n8. Schirmer ≥ 5 and ≤ 10 (without anesthesia)\n9. Best corrected visual acuity (BCVA) of 0.7 logMAR of better (logMAR \\\u003C0.7; Snellen equivalent score\n\nExclusion Criteria: DED Subjects receiving Xiidra®\n\n1. Have a known hypersensitivity or contraindication to the product or their components.\n2. Active ocular infection within the last 30 days.\n3. Any ocular surgical procedure within the last 6 months.\n4. Any subject who has previously tried and failed a course of lifitegrast.\n5. Unwilling to discontinue contact lens use for the duration of the study.\n6. Any female of childbearing potential (FOCBP) who is unwilling to agree to: a) Have a urine pregnancy testing performed at Baseline (Day 0) b) Use at least 1 medically acceptable form of birth control for at least 14 days prior to the first dose of study drug, throughout the study duration, and for 1 month after the last dose of investigational drug. NOTE: FOCBP include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) NOTE: Acceptable forms of birth control include:\n\n   * Mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom)\n   * Hormonal contraceptive (oral, injectable, implantable, or transdermal)\n   * Intrauterine device, or\n   * Surgical sterilization of male partner at least 3 months prior to the first dose of investigational drug NOTE: For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control when this is in line with the preferred and usual lifestyle of the subject; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.\n7. Any male who is unwilling to agree to use at least 1 medically acceptable form of birth control with female partner (FOCBP) who also is not using an acceptable form of birth control (as described above). NOTE: Acceptable forms of birth control include: • True abstinence (when this is in line with the preferred and usual lifestyle of the subject), or • Vasectomy at least 3 months prior to the first dose of study drug. Without a vasectomy, must use condoms with spermicidal foam, gel, film, cream, suppository at least 14 days prior to the first dose of investigational drug and throughout the study duration, and for 1 month after the last dose of the investigational drug.\n8. Pregnancy or lactation\n9. Current or past treatment with prescription drops for dry eye within the last six weeks.\n10. Any ocular condition that, in the opinion of the investigator, could affect study parameters including, but not limited to, lid margin disorders (e.g. Blepharitis, staphylococcal, demodex etc.)\n11. Any known history of immunodeficiency disorder, human immunodeficiency virus, hepatitis B or C, evidence of acute active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplant.\n12. Any known history of alcohol and\u002For drug abuse within 12 months prior to the screening visit that, in the opinion of the investigator, may have interfered with study compliance, outcome measures, safety parameters, and\u002For the general medical condition of the subject.\n\nInclusion Criteria: (Non-DED) subjects not receiving Xiidra® (non-treatment arm)\n\n1. At least 18 years of age or older at time of screening\n2. Ability to understand and provide informed consent\n3. No use of ophthalmic drops within 2 hours of tear fluid collection to minimize interference with baseline biomarker levels\n4. Willingness to comply with follow-up schedule and required visits\n5. No subject reported history of DED\n6. Schirmer ≥ 10 (without anesthesia)\n7. Best corrected visual acuity (BCVA) of 0.7 logMAR of better (logMAR \\\u003C0.7; Snellen equivalent score of 20\u002F100 or better) in each eye at the screening visit (Day 0).\n\nExclusion Criteria: (Non-DED) subjects not receiving Xiidra® (non-treatment arm)\n\n1. Active ocular infection within the last 30 days\n2. Any ocular surgical procedure within the last 6 months\n3. Unwilling to discontinue contact lens use for the duration of the study\n4. Pregnancy or lactation\n5. Any female of childbearing potential (FOCBP) who is unwilling to agree to: a) Have a urine pregnancy testing performed at Baseline (Day 0) b) Use at least 1 medically acceptable form of birth control for at least 14 days prior to the first dose of study drug, throughout the study duration, and for 1 month after the last dose of investigational drug. NOTE: FOCBP include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) NOTE: Acceptable forms of birth control include:\n\n   * Mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom)\n   * Hormonal contraceptive (oral, injectable, implantable, or transdermal)\n   * Intrauterine device, or\n   * Surgical sterilization of male partner at least 3 months prior to the first dose of investigational drug NOTE: For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control when this is in line with the preferred and usual lifestyle of the subject; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.\n6. Any male who is unwilling to agree to use at least 1 medically acceptable form of birth control with female partner (FOCBP) who also is not using an acceptable form of birth control (as described above). NOTE: Acceptable forms of birth control include: True abstinence (when this is in line with the preferred and usual lifestyle of the subject), or Vasectomy at least 3 months prior to the first dose of study drug. Without a vasectomy, must use condoms with spermicidal foam, gel, film, cream, suppository at least 14 days prior to the first dose of investigational drug and throughout the study duration, and for 1 month after the last dose of the investigational drug.\n7. History of DED diagnosis\n8. Any ocular condition that, in the opinion of the investigator, could affect study parameters including, but not limited to, lid margin disorders (eg. Blepharitis, staphylococcal, demodex etc.)\n9. Any known history of immunodeficiency disorder, human immunodeficiency virus, hepatitis B or C, evidence of acute active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplant.\n10. Any known history of alcohol and\u002For drug abuse within 12 months prior to the screening visit that, in the opinion of the investigator, may have interfered with study compliance, outcome measures, safety parameters, and\u002For the general medical condition of the subject.\n11. Any subject that has punctal occlusion such as permanent\u002Fsemi-permanent punctal plugs, temporary plugs, punctal cauterization",true,{"count":105,"type":20},36,[23],"This is a single-center prospective open-label, clinical trial to explore proteomic expression of tear fluid biomarkers in patients with dry eye treated with Lifitegrast.",[109,26],"Ocular Surface Disease",[58],"2026-03-18",{"date":113,"type":32},"2026-03-24",{"date":115,"type":20},"2026-03",{"date":117,"type":20},"2026-11",{"name":119,"class":39},"Pittsburgh Research Institute",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":69},"100614417","safety-and-efficacy-of-kelulut-honey-eyedrops-in-dry-eye-disease-100614417","NCT07279324","Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease","Pilot Study on the Safety and Efficacy of Kelulut Honey Eyedrops for Dry Eye Disease","Inclusion Criteria:\n\n1. Age 18-50 years at the time of consent.\n2. Clinical diagnosis of dry eye disease in at least one eye, based on symptoms and clinical signs (Symptomatic dry eye, defined as an OSDI score ≥ 13; objective evidence of tear film instability, such as TBUT \\\u003C 10 seconds in at least one eye)\n3. Participants may be Treatment-naïve, OR on stable dry eye treatment for at least 2 weeks before enrollment.\n4. Willing to use Kelulut honey eyedrops three times daily for 1 month as instructed.\n5. Able and willing to attend all study visits (Baseline, Week 2, Week 4).\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to honey, bee products, or any component of the study formulations.\n2. Active ocular infection or inflammation (e.g., infectious conjunctivitis, keratitis, uveitis).\n3. Severe allergic conjunctivitis or other ocular surface diseases\n4. Significant meibomian gland dysfunction or blepharitis\n5. Ocular surgery or laser procedures within the past 6 months.\n6. Use of topical ocular medications other than lubricants within the past 30 days\n7. Contact lens wear within 1 week prior to baseline or expected during the study.\n8. Punctal plugs or other lacrimal procedures within the last 3 months.\n9. Systemic diseases that significantly affect the ocular surface and are unstable or uncontrolled (e.g., uncontrolled Sjögren's, uncontrolled rheumatoid arthritis, uncontrolled diabetes).\n10. Participation in another clinical trial or receipt of an investigational product within the past 30 days.\n11. Pregnant or breastfeeding women, or those planning pregnancy during the study.","50 Years",{"count":129,"type":20},45,[52],"The goal of this clinical trial is to learn whether Kelulut honey eyedrops are safe and helpful in treating dry eye disease in adults. It will also learn about any side effects that may occur with the use of Kelulut honey eyedrops.\n\nThis Kelulut honey eyedrops are sterile ophthalmic solutions formulated with honey derived from stingless bees (Trigona spp.) at concentrations of 12.5% 25% and 50%. The eyedrop formulations are prepared according to a standardized laboratory protocol to ensure sterility, stability, and suitability for ocular use. Full formulation details are proprietary but can be provided to the ethics committee or regulatory authorities upon request.\n\nThe main questions this clinical trial aims to answer are:\n\n1. Does Kelulut honey improve tear film stability and dry eye symptoms?\n2. Are Kelulut honey eyedrops safe and well tolerated on the ocular surface?\n\nResearchers will compare different concentrations of Kelulut honey eyedrops to determine which concentration provides the best balance of safety and clinical benefit.\n\nParticipants will:\n\n1. Use Kelulut honey eyedrops (12.5%, 25%, or 50%) three times daily for 1 month, in addition to continuing their usual dry eye treatments.\n2. Attend scheduled follow-up visits (on week 2 and week 4) for eye examinations and dry eye assessments (e.g., TBUT, ocular surface staining, Schirmer test, and OSDI).\n3. Report any changes in symptoms or any discomfort, including stinging, redness, irritation, or other adverse effects experienced during the study.",[27,26,133],"Dry Eye Symptoms","2025-11-30",{"date":136,"type":32},"2025-12-12",{"date":138,"type":20},"2026-04-01",{"date":140,"type":20},"2026-10-30",{"name":142,"class":39},"Universiti Sains Malaysia",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":69},"100576054","phase-2-laser-acupuncture-on-dry-eye-and-sjgrens-syndrome-related-dry-eye-symptoms-ladesjs-100576054","NCT06780293","Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)","Exploring the Long-term Therapeutic Effects of Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms","LADESJS","• Dry eye syndrome\n\nInclusion Criteria:\n\n1. aged between 20 and 75 years\n2. Schirmer's test less than 10 mm\u002F5 min\n\nExclusion Criteria:\n\n1. Pregnancy\n2. With eye inflammation or infectious eye disease\n3. Accepted operation of eye\n\n   * Sjögren's syndrome\n\nInclusion Criteria:\n\n1. primary or secondary SS\n2. aged between 20 and 75 years\n3. fulfilled the 2002 American-European Consensus Criteria for SS (AECG)\n4. had no abnormal findings of immune, liver, kidney, or blood function evaluations.\n\nExclusion Criteria:\n\n1. a history of alcohol abuse, diabetes mellitus, or major life-threatening condition\n2. pregnancy or breastfeeding\n3. steroid pulse therapy within three months prior to the commencement of our study.","20 Years","75 Years",{"count":154,"type":20},140,[156],"PHASE2","This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of adding laser acupuncture at Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints to standard care for the treatment of dry eye symptoms in both Sjögren's Syndrome-related dry eye (SJS-DES) and non-Sjögren's Syndrome-related dry eye (Non-SJS-DES) populations. A total of 140 dry eye patients will be recruited and divided into two groups: 70 participants with SJS-DES and 70 with Non-SJS-DES. Participants will be randomly assigned into three groups: Sham+LA group (60 participants receiving 4 weeks of placebo laser acupuncture followed by 4 weeks of active laser acupuncture), LA+LA group (60 participants receiving 4 weeks of active laser acupuncture followed by another 4 weeks of active laser acupuncture), and a Waiting List group (20 participants receiving no laser acupuncture treatment). Each session will target the Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints bilaterally, performed twice a week. The total study period is 8 weeks, and the treatment efficacy will be assessed at the end of the 8-week treatment. The Waiting List group (20 participants) will not receive any laser acupuncture treatment during this period. Efficacy will be evaluated using the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination. This study aims to investigate the impact of laser acupuncture on dry eye symptom improvement and the potential markers that differentiate between SJS-DES and Non-SJS-DES patients. The goal is to develop a comprehensive integrated care model for early screening, diagnosis, and personalized treatment plans for Dry Eye Syndrome and Sjögren's Syndrome, achieving the ultimate objective of \"Holistic Health Care.\"",[26,159,160],"Laser Acupuncture","Sjögren's Syndrome (SS)",[162,163,159,164,165,166,167],"Dry eye syndrome","Sjögren's syndrome","Fengchi (GB20)","Zanzhu (BL2)","Hegu (LI4)","Quchi (LI11)","2025-04-07",{"date":170,"type":32},"2025-04-09",{"date":172,"type":32},"2025-02-03",{"date":174,"type":20},"2026-12-31",{"name":176,"class":177},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":103,"sex":16,"minAge":151,"maxAge":152,"enrollmentInfo":185,"targetDuration":4,"studyType":187,"phases":4,"briefSummary":188,"conditions":189,"keywords":192,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":205,"locationsCount":69},"100575372","exosomes-proteomic-for-sjogrens-syndrome-and-dry-eye-syndrome-100575372","NCT06771427","Exosomes Proteomic for Sjogren's Syndrome and Dry Eye Syndrome","Systemic Proteomic Analysis of Plasma Exosomes to Explore the Immunomodulation Reflected to Sjogren's Syndrome and Dry Eye Syndrome","Dry eye syndrome\n\nInclusion Criteria: aged between 20 and 75 years Schirmer's test less than 10 mm\u002F5 min Exclusion Criteria: Pregnancy With eye inflammation or infectious eye disease Accepted operation of eye Sjögren's syndrome\n\nInclusion Criteria: primary or secondary SS aged between 20 and 75 years fulfilled the 2002 American-European Consensus Criteria for SS (AECG) had no abnormal findings of immune, liver, kidney, or blood function evaluations.\n\nExclusion Criteria: a history of alcohol abuse, diabetes mellitus, or major life-threatening condition pregnancy or breastfeeding steroid pulse therapy within three months prior to the commencement of our study.\n\nnon AIDDES Healthy Controls\n\nInclusion Criteria: aged between 20 and 75 years without any Chronic disease Exclusion Criteria: any Sjögren's syndrome or Dry eye syndrome.",{"count":186,"type":20},220,"OBSERVATIONAL","By analyzing the differential proteins in exosomes, this study aims to understand the pathological mechanisms of SJS and DES, identify potential diagnostic and therapeutic methods, and advance the diagnosis and treatment of these diseases.",[26,190,191],"Sjogren's Syndrome","Xerophthalmia",[162,163,191,193,194,195,196,197,198],"Chinese herbal tea","Nourishing Yin and Moistening Dryness","Exosome","GB20","BL2","proteomics","2025-01-15",{"date":201,"type":32},"2025-01-17",{"date":203,"type":32},"2025-01-16",{"date":174,"type":20},{"name":176,"class":177}]