A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease (NCT06544694) | Clinical Trial Compass
CompletedPhase 3
A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease
United States80 participantsStarted 2024-10-08
Plain-language summary
The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Have a previous history of DED, clinician diagnosed or patient reported, within the previous 6 months prior to the Screening visit.
* Have used artificial tears for DED symptoms within 2 months prior to the Screening visit.
* Corrected visual acuity equal to or better than logarithm Minimum angle of reflection (logMar) +0.7 (Snellen equivalent equal to or better than 20/100), as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at both the Screening and Baseline visits.
* Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history.
* Other protocol specified inclusion criteria may apply.
Key Exclusion Criteria:
* History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety.
* Current evidence of other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease which the investigator believes may interfere with study findings or interpretation.
* History of ocular surgery within 1 year prior to the Screening visit; history of corneal transplant in one or both eyes.
* Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study.
* Regular use, as assessed by the investigator, of lid hygiene or…
What they're measuring
1
Least Squares Mean Percentage Change From Baseline in Goblet Cell Density at Day 90 for 0.003% AR-15512
Timeframe: Day 1 pre-instillation (Baseline), Day 90 post instillation