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Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy

Sponsor
Virdi Eye Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01475877
Collaborator
(none)
20
Enrollment
1
Location
12
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
20 participants
Time Perspective:
Prospective
Official Title:
Bromday (Bromfenac Ophthalmic Solution)0.09% QD vs Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Control of Pain and Epithelial Healing Post (PRK)
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Nepafenac

Drug: Bromfenac
Bromfenac 0.09% 1 drop in study eyes q day
Other Names:
  • Bromday

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post-PRK pain [7 days]

    Secondary Outcome Measures

    1. Post-PRK epithelial healing [7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virdi Eye Clinic and Laser Vision Center Rock Island Illinois United States 61201

    Sponsors and Collaborators

    • Virdi Eye Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virdi Eye Clinic
    ClinicalTrials.gov Identifier:
    NCT01475877
    Other Study ID Numbers:
    • MAC-02-11
    First Posted:
    Nov 21, 2011
    Last Update Posted:
    May 3, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Virdi Eye Clinic
    bromfenac
    nepafenac
    PRK
    epithelial healing,
    Additional relevant MeSH terms:
    Myopia
    Bromfenac

    Study Results

    No Results Posted as of May 3, 2016