NCT00330798

Brief Summary

The purpose of this study is to compare healing times and subjective pain level responses of nepafenac to placebo after photo refractive keratomileusis (PRK) surgery.

Trial Health

87
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 Feb 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

May 1, 2012

Enrollment Period

4 months

First QC Date

May 25, 2006

Last Update Submit

November 17, 2016

Conditions

Photorefractive Keratectomy

Keywords

Photorefractive Keratectomy

Outcome Measures

Primary Outcomes (1)

  • Subjective pain

    Day 5

Secondary Outcomes (1)

  • Rate of epithelial healing

    Time to event

Study Arms (2)

Nevanac

EXPERIMENTAL

One drop, three times daily, in the assigned eye for the first three postoperative days

Drug: nepafenac 0.1%

Acular LS

PLACEBO COMPARATOR

One drop, three times daily, in the assigned eye for the first three postoperative days

Other: ketorolac 0.4%

Interventions

nepafenac 0.1%DRUG

Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use.

Nevanac
ketorolac 0.4%OTHER

Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use.

Acular LS

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older with healthy ocular status and pre-operative refractive anisometropia of less than 2.000 diopters between eyes undergoing bilateral PRK surgery.

You may not qualify if:

  • Those desiring PRK in only one eye, those in need of additional topical eye medications, those with history of drug/alcohol abuse, women breastfeeding or pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lackland Air Force Base

San Antonio, Texas, 78236, United States

Location

Related Publications (1)

  • Caldwell M, Reilly C. Effects of topical nepafenac on corneal epithelial healing time and postoperative pain after PRK: a bilateral, prospective, randomized, masked trial. J Refract Surg. 2008 Apr;24(4):377-82. doi: 10.3928/1081597X-20080401-11.

    PMID: 18500088RESULT

Study Officials

  • Matthew Caldwell

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2006

First Posted

May 29, 2006

Study Start

February 1, 2006

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

November 18, 2016

Record last verified: 2012-05

Locations

US(1)