Phase 3
Completed N=241
OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Post-Surgical Ocular Pain · Post-Surgical Ocular Inflammation
Source: ClinicalTrials.gov NCT02089113 ↗
Enrolled (actual)
241
Serious AEs
0.4%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants With an Absence of Anterior Chamber Inflammation — 63; 25 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Absence of Anterior Chamber Inflammation |
63; 25 | — |
| PRIMARY Number of Participants With an Absence of Ocular Pain |
124; 47 | — |
Eligibility Criteria
Inclusion Criteria
- Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a 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
Data sourced from ClinicalTrials.gov (NCT02089113). 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.