Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy

May 1, 2016 updated by: Virdi Eye Clinic

Bromday (Bromfenac Ophthalmic Solution)0.09% QD vs Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Control of Pain and Epithelial Healing Post (PRK)

This study will compare the effect of two topical non-steroidal antiinflammatory agents to control pain after photorefractive keratectomy (PRK) eye surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

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
    • Illinois
      • Rock Island, Illinois, United States, 61201
        • Virdi Eye Clinic and Laser Vision Center

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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing photorefractive keratectomy in both eyes

Description

Inclusion Criteria:

  • male or female at least 18 years of age,
  • no other ocular studies with 15 days prior to dosing,
  • BCVA 20/200 or better,
  • return for study visits and follow instructions from investigator and staff,
  • self administer test article

Exclusion Criteria:

  • Ocular inflammation,
  • hypersensitivity to bromfenac or nepafenac,
  • any corneal pathology,
  • have had radial keratotomy,
  • corneal transplant or corneal refractive surgery in the last two years

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nepafenac
Drug: Bromfenac
Bromfenac 0.09% 1 drop in study eyes q day
Other Names:
  • Bromday

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-PRK pain
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-PRK epithelial healing
Time Frame: 7 days
7 days

Collaborators and Investigators

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

Sponsor

Virdi Eye Clinic

Investigators

  • Principal Investigator: Navaneet S Borisuth, MD,PhD, Virdi Eye Clinic

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

May 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 16, 2011

First Posted (ESTIMATE)

November 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 1, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAC-02-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In the observational study conducted, there was no significant difference in pain levels or epithelial healing of post-photorefractive keratectomy patients who were treated with bromfenac 0.09% or nepafenac 0.1%

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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