Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | January 2017 |
| Contact: | Deepa Mulani |
| Email: | dmulani@ocutx.com |
| Phone: | 781-357-4023 |
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.
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.
Inclusion Criteria:
- Has a cataract and is expected to undergo clear corneal cataract surgery with
phacoemulsification and implantation of 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
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