Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy
Bromday (Bromfenac Ophthalmic Solution)0.09% QD vs Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Control of Pain and Epithelial Healing Post (PRK)
1 other identifier
observational
20
1 country
1
Brief Summary
This study will compare the effect of two topical non-steroidal antiinflammatory agents to control pain after photorefractive keratectomy (PRK) eye surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
November 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 3, 2016
May 1, 2016
1 year
November 7, 2011
May 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-PRK pain
7 days
Secondary Outcomes (1)
Post-PRK epithelial healing
7 days
Study Arms (1)
Nepafenac
Interventions
Eligibility Criteria
All patients undergoing photorefractive keratectomy in both eyes
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virdi Eye Cliniclead
Study Sites (1)
Virdi Eye Clinic and Laser Vision Center
Rock Island, Illinois, 61201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Navaneet S Borisuth, MD,PhD
Virdi Eye Clinic
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
November 21, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 3, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share
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%