Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Virdi Eye Clinic.
Recruitment status was  Recruiting
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
  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 ]

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
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

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
Ophthalmic Solutions
Bromfenac
Nepafenac
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014