OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Ocular Therapeutix

Status and phase: Completed; Phase 3

Conditions: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation

Treatments: Drug: Dexamethasone; Other: Placebo Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02736175

OTX-15-003

Details and patient eligibility

About

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

Enrollment: 438 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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438 participants in 2 patient groups, including a placebo group

OTX-DP

Experimental group

Description:

OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use

Treatment:

Drug: Dexamethasone

PV

Placebo Comparator group

Description:

PV (placebo drug delivery vehicle)

Treatment:

Other: Placebo Vehicle