Phase 3
N=258
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Keratoconjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT02845674 ↗Enrolled (actual)
258
Serious AEs
3.1%
Results posted
Dec 2018
Primary outcome: Primary: Adverse Events — 68; 81 Count of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OTX-101 0.09% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries Limited
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
68; 81 | — |
Summary
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)
Eligibility Criteria
Inclusion Criteria
- Completion of Study OTX-101-2016-001
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT02845674). 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.