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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01475877
Other study ID # MAC-02-11
Secondary ID
Status Completed
Phase Phase 4
First received November 7, 2011
Last updated May 1, 2016
Start date May 2011
Est. completion date May 2012

Study information

Verified date May 2016
Source Virdi Eye Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Bromfenac
Bromfenac 0.09% 1 drop in study eyes q day

Locations

Country Name City State
United States Virdi Eye Clinic and Laser Vision Center Rock Island Illinois

Sponsors (1)

Lead Sponsor Collaborator
Virdi Eye Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-PRK pain 7 days No
Secondary Post-PRK epithelial healing 7 days No
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