Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Phase 3
Completed
- Conditions
- Post Ocular Surgical Inflammation and Pain
- Interventions
- Drug: Punctum Plug
- Registration Number
- NCT02034019
- Lead Sponsor
- Ocular Therapeutix, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OTX-DP (Dexamethasone Punctum Plug) Punctum Plug Resorbable hydrogel drug delivery vehicle containing dexamethasone PVPP (Placebo Punctum Plug) Punctum Plug Resorbable hydrogel drug delivery vehicle containing no drug OTX-DP (Dexamethasone Punctum Plug) Dexamethasone Resorbable hydrogel drug delivery vehicle containing dexamethasone
- Primary Outcome Measures
Name Time Method Absence of Cells in Anterior Chamber of the Study Eye Day 14 Absence of Pain in Study Eye Day 8
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie OTX-DP's sustained release of dexamethasone for post-cataract inflammation?
How does OTX-DP compare to topical corticosteroids in managing post-surgical ocular inflammation and pain?
Are there specific biomarkers that predict response to dexamethasone-based sustained release therapies in post-cataract patients?
What adverse events are associated with canalicular dexamethasone depot placement in NCT02034019 and how were they managed?
What are the current developments in corticosteroid-based sustained release implants for post-ocular surgery inflammation by Ocular Therapeutix, Inc.?
Trial Locations
- Locations (1)
Texan Eye / Keystone Research, Ltd.
🇺🇸Austin, Texas, United States
Texan Eye / Keystone Research, Ltd.🇺🇸Austin, Texas, United States