A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery

June 11, 2015 updated by: Allergan
This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

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
    • California
      • Newport Beach, California, United States

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:

  • Planned single cataract extraction with lens implant
  • Best-corrected visual acuity of 20/200 or better in the opposite eye

Exclusion Criteria:

  • Glaucoma or history of intraocular hypertension in the study eye
  • History of chronic ocular allergy in the last year requiring treatment
  • Scheduled for cataract surgery in the non-study eye during study participation

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone Drug Delivery System
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Drug: Dexamethasone Drug Delivery System
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Placebo Comparator: Placebo Drug Delivery System
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Drug: Placebo Drug Delivery System
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Clearance of Anterior Chamber Inflammation
Time Frame: Up to Day 71
The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst).
Up to Day 71

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Levels of Dexamethasone
Time Frame: Day 2, Day 7, Day 14
Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.
Day 2, Day 7, Day 14

Collaborators and Investigators

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

Sponsor

Allergan

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

June 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206207-027

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.

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