Post Ocular Surgical Inflammation and Pain Clinical Trial
| Verified date | January 2020 |
| Source | Ocular Therapeutix, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 247 |
| Est. completion date | February 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Texan Eye / Keystone Research, Ltd. | Austin | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Ocular Therapeutix, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Absence of Cells in Anterior Chamber of the Study Eye | Day 14 | ||
| Primary | Absence of Pain in Study Eye | Day 8 |