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

January 22, 2020 updated by: Ocular Therapeutix, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

247

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78731
        • Texan Eye / Keystone Research, Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OTX-DP (Dexamethasone Punctum Plug)
Resorbable hydrogel drug delivery vehicle containing dexamethasone
Drug: Dexamethasone
Drug: Punctum Plug
Placebo Comparator: PVPP (Placebo Punctum Plug)
Resorbable hydrogel drug delivery vehicle containing no drug
Drug: Punctum Plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of Cells in Anterior Chamber of the Study Eye
Time Frame: Day 14
Day 14
Absence of Pain in Study Eye
Time Frame: Day 8
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Investigators

  • Study Director: Clinical Project Manager, Ocular Therapeutix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-13-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Ocular Surgical Inflammation and Pain

Clinical Trials on Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe