Bromday Versus Nevanac Eye Drops to Control Pain Followin... | NCT01475877

Studies
Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy

NCT01475877

Sponsor

Virdi Eye Clinic

Status

Completed

Last Update Posted

May 3, 2016Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Myopia

Interventions

Bromfenac

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Nov 7, 2011

First Submission Date that Met QC Criteria

Nov 16, 2011

First Posted Date

Nov 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2016

Last Update Posted Date

May 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will compare the effect of two topical non-steroidal antiinflammatory agents to control pain after photorefractive keratectomy (PRK) eye surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nepafenac			Drug: Bromfenac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bromfenac	Drug	Bromfenac 0.09% 1 drop in study eyes q day	Nepafenac

Measure	Description	Time Frame
Post-PRK pain		7 days

Measure	Description	Time Frame
Post-PRK epithelial healing		7 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients undergoing photorefractive keratectomy in both eyes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Navaneet S Borisuth, MD,PhD	Virdi Eye Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virdi Eye Clinic and Laser Vision Center		Rock Island	Illinois	61201	United States

IPD Sharing Statement Module

Plan to Share IPD

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%

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C053083	bromfenac

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided