NCT00347204

Brief Summary

To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS \& Nevanac) to help control pain following Photorefractive Keratectomy (PRK).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_4

Status
completed

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

January 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

July 4, 2006

Status Verified

June 1, 2006

First QC Date

June 29, 2006

Last Update Submit

June 29, 2006

Conditions

MyopiaHyperopia

Keywords

PRKlaser vision correctionsurface ablationpainwound healingcorneal haze

Outcome Measures

Primary Outcomes (4)

  • Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK

  • Best-corrected Visual acuity at all study visits

  • Degree of corneal haze at all study visits

  • Time to epithelial closure in each eye after PRK

Interventions

ketorolac (Acular LS)DRUG
Nepafenac (Nevanac)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing PRK for myopia or hyperopia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyopiaHyperopiaPainCorneal Opacity

Interventions

Ketorolacnepafenac

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCorneal Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • William Trattler, MD

    Center For Excellence In Eye Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2006

First Posted

July 4, 2006

Study Start

January 1, 2006

Study Completion

June 1, 2006

Last Updated

July 4, 2006

Record last verified: 2006-06