Phase 3
N=247
Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Post Ocular Surgical Inflammation and Pain
Bottom Line
View on ClinicalTrials.gov: NCT02034019 ↗Enrolled (actual)
247
Serious AEs
0.4%
Results posted
Jan 2020
Primary outcome: Primary: Absence of Cells in Anterior Chamber of the Study Eye — 54; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Punctum Plug (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ocular Therapeutix, Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Cells in Anterior Chamber of the Study Eye |
54; 12 | — |
| PRIMARY Absence of Pain in Study Eye |
131; 36 | — |
Summary
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
Eligibility Criteria
Inclusion Criteria
- Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
- Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes
Exclusion Criteria
- Any intraocular inflammation in the study eye present during the screening slit lamp examination
- Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
- Any intraocular inflammation in the study eye present during the screening slit lamp examination
Data sourced from ClinicalTrials.gov (NCT02034019). 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.