About this trial
Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.This prospective, open label study will include 60 eyes of 30 OK lens related dry eye patients.Participants will receive 3% Diquafosol ophthalmic solution. The dosage for both drugs will be one drop, six times per day for 4 weeks. Pediatric Refractive Error Profiletear(PREP), tear film lipid layer (TFLL),non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), tear meniscus height (TMH), objective visual quality,ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28
Eligibility criteria
Qualifiers
Age 8-18 years old
Wearing corneal shape mirror more than one year and at least eight hours every night
Myopia -5.50 to -1.00 D, astigmatism < 1.75 D, or curvature between 41.00 and 46.00D, astigmatism < -0.75D, and best corrected visual acuity ≥1.0.
Diagnosis of dry eye: patients complained of dry eye, foreign body sensation, burning sensation, fatigue, discomfort, envy, subjective symptom such as vision fluctuation; (a) OSDI questionnaire score >13 points, and (b) NITBUT <10 s or (c) ocular surface dyeing assessment > 5 corneal spots/more than nine conjunctival spots.
Disqualifiers
Suffering from allergic or autoimmune disease associated with dry eye of the participants are not suitable for wearing OK lens
Pathological changes in the corneal rim
Eyelid rim lesions, cornea, uveitis, retina and other systemic diseases may affect the ocular surface. Examples include severe ocular surface diseases (Sjögren's syndrome, allergic conjunctivitis, ocular papules, conjunctival chafing, conjunctival scarring, and chemical damage);
Received any dry eye treatment within 14 days prior to the start of this study or continued use of other topical eye drops that would affect the results of the study.
Trial design
Treatments tested in this trial
- 3% Diquafosol tetrasodium