A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease
- Conditions
- Dry Eye Disease
- Interventions
- Drug: 0.003% AR-15512Other: Artificial Tears
- Registration Number
- NCT06544694
- Lead Sponsor
- Alcon Research
- Brief 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).
- Detailed Description
Qualified subjects will enter a 14-day run-in period, followed by a 13-week randomized treatment period, for a total individual duration of participation of approximately 15 weeks. During the run-in period, subjects will administer Artificial Tears (REFRESH® Classic) as one drop in each eye twice daily.
This is a Phase 3b study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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
- 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 heat masks within 14 days prior to the Screening visit or any planned use during the study.
- Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit or anticipated during the study.
- Other protocol-specified exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.003% AR-15512 0.003% AR-15512 One drop in each eye twice daily for 90 days (treatment period) Artificial Tears Artificial Tears One drop in each eye twice daily for 90 days (treatment period)
- Primary Outcome Measures
Name Time Method Percentage change from baseline in goblet cell density at Day 90 Baseline (Day 1 pre-instillation), Day 90 Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva will be collected on filter papers based on a technique called impression cytology. The filter papers will then be processed in a lab to identify the number of goblet cells. The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) will be calculated. A positive change value will indicate an improvement.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Oculus Research
🇺🇸Garner, North Carolina, United States
Wilmington Eye
🇺🇸Leland, North Carolina, United States
CORE, Inc.
🇺🇸Shelby, North Carolina, United States
Butchertown Clinical Trials
🇺🇸Houston, Texas, United States