Phase 3
N=81
A Study Designed to Evaluate Tear Production
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT06544707 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1 — 519.65 micrometers — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 0.003% AR-15512 ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1 |
519.65 | <0.0001 sig |
| PRIMARY Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 2 |
503.80 | <0.0001 sig |
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).
Eligibility Criteria
Key Inclusion Criteria
- 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.
- Corrected visual acuity score of 20/200 or better in both eyes.
- 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
- 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.
- Used artificial tears within 2 hours of the Study Visit.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT06544707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.