Phase 3 N=241 Randomized Double-blind Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT02089113 ↗

Enrolled (actual)

241

Serious AEs

0.4%

Results posted

Mar 2016

Primary outcome: Primary: Number of Participants With an Absence of Anterior Chamber Inflammation — 63; 25 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dexamethasone (Drug); Placebo Vehicle (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ocular Therapeutix, Inc.
Primary completion: Jan 2015

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	—

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

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

View full record on ClinicalTrials.gov →

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.