Phase 3
Completed N=258
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Keratoconjunctivitis Sicca
Source: ClinicalTrials.gov NCT02845674 ↗
Enrolled (actual)
258
Serious AEs
3.1%
Results posted
Dec 2018
Primary outcomePrimary: Adverse Events — 68; 81 Count of participants
◆ Published Evidence
Emerging
15citations · ~3 / year
Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca.
Summary
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)
Linked Publications
-
Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
68; 81 | — |
Eligibility Criteria
Inclusion Criteria
- Completion of Study OTX-101-2016-001
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT02845674) and the linked publication. 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.