Phase 2
Completed N=153
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.
Source: ClinicalTrials.gov NCT04362670 ↗Enrolled (actual)
153
Serious AEs
2.0%
Results posted
Nov 2023
Primary outcomePrimary: Number of Subjects With At Least One (1) Treatment Emergent Adverse Event — 0; 16; 15; 5 count of participants
Summary
To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With At Least One (1) Treatment Emergent Adverse Event |
0; 16; 15; 5; 1 | — |
| PRIMARY Schirmer Test Score, CFB at Week 12 |
1.98; 1.91; 2.24; 3.08 | — |
Eligibility Criteria
Inclusion Criteria
- Dry eye disease diagnosis
- VAS eye dryness severity score ≥ 30.
Exclusion Criteria
- Are unwilling to discontinue use of contact lenses
- Are unwilling to withhold use of artificial tears.
Data sourced from ClinicalTrials.gov (NCT04362670). 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. Informational only — not medical advice.