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Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy

This study is currently recruiting participants.
Verified November 2011 by Virdi Eye Clinic
Sponsor:
Information provided by (Responsible Party):
Virdi Eye Clinic
ClinicalTrials.gov Identifier:
NCT01475877
First received: November 7, 2011
Last updated: November 20, 2011
Last verified: November 2011
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: May 2012
Estimated 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475877

Contacts
Contact: Cheryl Swanson, COT 3097885524 eyes@virdieyemd.com
Contact: Susan Eaker 3097885524 eyes@virdieyemd.com

Locations
United States, Illinois
Virdi Eye Clinic and Laser Vision Center Recruiting
Rock Island, Illinois, United States, 61201
Contact: Cheryl Swanson, COT     309-788-5524     eyes@virdieyemd.com    
Contact: Susan Eaker     3097885524     eyes@virdieyemd.com    
Principal Investigator: Navaneet S Borisuth, M.D., Ph.D.            
Sub-Investigator: Matt Rauen, M.D.            
Sponsors and Collaborators
Virdi Eye Clinic
Investigators
Principal Investigator: Navaneet S Borisuth, MD,PhD Virdi Eye Clinic
  More Information

No publications provided

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: November 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Virdi Eye Clinic:
bromfenac
nepafenac
PRK
epithelial healing,

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013