Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

March 17, 2009 updated by: Bp Consulting, Inc
To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

166

Phase

  • Phase 4

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19124
        • Soll Eye Associates

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:

  • Patients must be diagnosed with acute pseudophakic CME within 12 months of cataract surgery
  • Males and females 18 years and older
  • Able to provide written informed consent

Exclusion Criteria:

  • Complicated cataract surgery, particularly posterior capsule rupture and vitreous loss
  • Pre-Existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker
  • History of Uveitis
  • Ipsilateral intraocular surgery prior to cataract surgery
  • CME greater than one year duration

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Drug: Bromfenac
1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
ACTIVE_COMPARATOR: 2
Drug: Ketorolac
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
ACTIVE_COMPARATOR: 3
Drug: Diclofenac
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute Pseudophakic Cystoid Macular Edema
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity
Time Frame: 5 months
5 months

Collaborators and Investigators

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

Sponsor

Bp Consulting, Inc

Investigators

  • Principal Investigator: David Rho, MD, Soll Eye Associates

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

January 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (ESTIMATE)

January 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2009

Last Update Submitted That Met QC Criteria

March 17, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5349

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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