Phase 2
Completed N=60
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Ocular Inflammation and Pain
Source: ClinicalTrials.gov NCT01666210 ↗
Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Apr 2017
Primary outcomePrimary: Absence of Cells in Anterior Chamber of Study Eye — 6; 3 Participants
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 ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Cells in Anterior Chamber of Study Eye |
6; 3 | — |
| PRIMARY Absence of Pain in the Study Eye |
23; 9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01666210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.