Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/23/2013 |
| Start Date: | October 2012 |
| Contact: | Stephen Curwen |
| Email: | scurwen@ocutx.com |
| Phone: | 781-357-4009 |
A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase II Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
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 ocular inflammation
and pain in subjects who have undergone cataract extraction with intra-ocular lens
implantation.
Inclusion Criteria:
- Has provided written informed consent, approved by the appropriate institutional
review board; and is able to comply with study requirements and visit schedule
- Is greater than or equal to 21 years of age
- Has a cataract and is expected to undergo clear corneal cataract surgery with
phacoemulsification and implantation of a posterior chamber intraocular lens
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 at Screening
- Compromised immune system or an autoimmune disease that in the opinion of the
Investigator could affect the quality of the ocular surface
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