Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Ocular Therapeutix

Status and phase: Completed; Phase 3

Conditions: Post Ocular Surgical Inflammation and Pain

Treatments: Drug: Punctum Plug; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02034019

OTX-13-002

Details and patient eligibility

About

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 post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Enrollment: 247 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 a posterior chamber intraocular 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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247 participants in 2 patient groups, including a placebo group

OTX-DP (Dexamethasone Punctum Plug)

Active Comparator group

Description:

Resorbable hydrogel drug delivery vehicle containing dexamethasone

Treatment:

Drug: Dexamethasone

Drug: Punctum Plug

PVPP (Placebo Punctum Plug)

Placebo Comparator group

Description:

Resorbable hydrogel drug delivery vehicle containing no drug

Treatment:

Drug: Punctum Plug