Phase 3
N=55
A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT06660290 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention — 0; 3.6 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 0.003% AR-15512 ophthalmic solution (Drug); Artificial tears (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention |
0; 3.6 | — |
Summary
The purpose of this study is to evaluate the percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic).
Eligibility Criteria
Key Inclusion Criteria
- Corrected Visual Acuity (Snellen) 20/200 or better in both eyes;
- Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history;
- Capable of giving signed informed consent.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria
- Current evidence of other clinically significant ophthalmic disease other than dry eye;
- History of ocular surgery within 1 year of the Study Visit;
- Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit;
- Positive pregnancy test or currently breastfeeding.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT06660290). 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.