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

Phase 3

Completed

• Conditions: Post Ocular Surgical Inflammation and Pain
• Interventions: Drug: Dexamethasone; Drug: Punctum Plug

• Registration Number: NCT02034019
• Lead Sponsor: Ocular Therapeutix, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Study Start: 2014-02
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Results First Submitted: 2016-02-29
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-22
• Last Update Submitted: 2020-01-22
• Results First Posted: 2020-01-31
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTX-DP (Dexamethasone Punctum Plug)	Punctum Plug	Resorbable hydrogel drug delivery vehicle containing dexamethasone
PVPP (Placebo Punctum Plug)	Punctum Plug	Resorbable hydrogel drug delivery vehicle containing no drug
OTX-DP (Dexamethasone Punctum Plug)	Dexamethasone	Resorbable hydrogel drug delivery vehicle containing dexamethasone

Primary Outcome Measures

Name	Time	Method
Absence of Pain in Study Eye	Day 8
Absence of Cells in Anterior Chamber of the Study Eye	Day 14

Trial Locations

Locations (1)

Texan Eye / Keystone Research, Ltd.; 🇺🇸 Austin, Texas, United States