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

A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3C Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

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

Study Overview

• Status: Completed
• Conditions: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation
• Intervention / Treatment: Drug: Dexamethasone; Other: Placebo Vehicle

• Study Type: Interventional
• Enrollment (Actual): 438
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OTX-DP; OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use	Drug: Dexamethasone
Placebo Comparator: PV; PV (placebo drug delivery vehicle)	Other: Placebo Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of Anterior Chamber Inflammation	Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14	Day 14
Absence of Ocular Pain	Absence of pain (i.e., score of '0') in the study eye at Day 8	Day 8

Collaborators and Investigators

• Sponsor: Ocular Therapeutix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; Cataract; Capsule Opacification; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: OTX-15-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO