OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Phase 3
Completed
- Conditions
- Post-Surgical Ocular PainPost-Surgical Ocular Inflammation
- Interventions
- Procedure: Placebo Vehicle
- Registration Number
- NCT02089113
- Lead Sponsor
- Ocular Therapeutix, Inc.
- Brief Summary
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
Inclusion Criteria
- Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OTX-DP Dexamethasone OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use PV Placebo Vehicle PV (placebo drug delivery vehicle)
- Primary Outcome Measures
Name Time Method Number of Participants With an Absence of Anterior Chamber Inflammation Day 14 Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14
Number of Participants With an Absence of Ocular Pain Day 8 Absence of pain (i.e., score of '0') in the study eye at Day 8
- Secondary Outcome Measures
Name Time Method