Status:
COMPLETED
A Study Designed to Evaluate Tear Production
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate tear production following acute administration of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) in subjects with dry eye disease (DED).
Detailed Description
Qualified subjects will attend a single visit. This is a Phase 3b. 2 stage study. In Phase 1, approximately 40 subjects will be enrolled, after which the study will be paused and an analysis will be ...
Eligibility Criteria
Inclusion
- Key
- Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported.
- Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms.
- Have a corrected visual acuity score of 20/200 or better in both eyes.
- Have 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
- Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration).
- History of ocular surgery within 1 year of the Study Visit.
- Use of contact lenses in either eye within 7 days of the Study Visit.
- Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit.
- Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit.
- Other protocol-specified exclusion criteria may apply.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT06544707
Start Date
October 15 2024
End Date
January 30 2025
Last Update
February 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Eye Research Foundation
Newport Beach, California, United States, 92663