SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
ConditionDry Eye Disease (DED)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
This is a prospective, randomized, double-masked, multi-site clinical trial designed to compare the efficacy of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED). The primary goal is to determine whether SYSTANE® PRO is non-inferior to MIEBO™ after one month of treatment, based on change in Ocular Surface Disease Index (OSDI) scores.
Eligibility criteria
Qualifiers
Adults>=18 years of age
Corrected visual acuity of 20/100 or better in both eyes
Ocular Surface Disease Index [OSDI] scores between 23 and 50 units [inclusive]
Tear break up time score of <=5 seconds in both eyes
Disqualifiers
Discontinue contact lens wear starting 7 days prior and throughout the study
Artificial tears and warm compresses should not be used for at least one week prior to enrollment and throughout the study
Systemic health conditions that are known to alter tear film physiology(e.g., primary and secondary Sjogren's syndrome)
History of ocular surgery within the past 12 months
Trial design
Treatments tested in this trial
- SYSTANE® PRO
- MIEBO™ (Perfluorohexyloctane, PFHO)
Treatment groups
260 Participants
are divided into 2 treatment groupsSponsors and collaborators
Indiana University
Lead sponsor
Alcon Research
Collaborator
Source ClinicalTrials.gov