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Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virdi Eye Clinic
ClinicalTrials.gov Identifier:
NCT01475877
First received: November 7, 2011
Last updated: May 1, 2016
Last verified: May 2016
  Purpose
This study will compare the effect of two topical non-steroidal antiinflammatory agents to control pain after photorefractive keratectomy (PRK) eye surgery.

Condition Intervention Phase
Myopia
Drug: Bromfenac
Phase 4

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Virdi Eye Clinic:

Primary Outcome Measures:
  • Post-PRK pain [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-PRK epithelial healing [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nepafenac Drug: Bromfenac
Bromfenac 0.09% 1 drop in study eyes q day
Other Name: Bromday

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475877

Locations
United States, Illinois
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
  More Information

Responsible Party: Virdi Eye Clinic
ClinicalTrials.gov Identifier: NCT01475877     History of Changes
Other Study ID Numbers: MAC-02-11 
Study First Received: November 7, 2011
Last Updated: May 1, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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:
bromfenac
nepafenac
PRK
epithelial healing,

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

ClinicalTrials.gov processed this record on September 23, 2016