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Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy

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ClinicalTrials.gov Identifier: NCT01475877
Recruitment Status : Completed
First Posted : November 21, 2011
Last Update Posted : May 3, 2016
Information provided by (Responsible Party):
Virdi Eye Clinic

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
Myopia Drug: Bromfenac Phase 4

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 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Group/Cohort Intervention/treatment
Nepafenac Drug: Bromfenac
Bromfenac 0.09% 1 drop in study eyes q day
Other Name: Bromday

Primary Outcome Measures :
  1. Post-PRK pain [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Post-PRK epithelial healing [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing photorefractive keratectomy in both eyes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475877

United States, Illinois
Virdi Eye Clinic and Laser Vision Center
Rock Island, Illinois, United States, 61201
Sponsors and Collaborators
Virdi Eye Clinic
Principal Investigator: Navaneet S Borisuth, MD,PhD Virdi Eye Clinic

Responsible Party: Virdi Eye Clinic
ClinicalTrials.gov Identifier: NCT01475877     History of Changes
Other Study ID Numbers: MAC-02-11
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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%

Keywords provided by Virdi Eye Clinic:
epithelial healing,

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents