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CompletedNCT00330798Updated Nov 18, 2016

A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief

A Phase 4 interventional study of nepafenac 0.1% and ketorolac 0.4% in Photorefractive Keratectomy, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by Alcon Research · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Photorefractive Keratectomy

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Keywords

  • Photorefractive Keratectomy
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's enrollment of 40 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 19 years or older with healthy ocular status and pre-operative refractive anisometropia of less than 2.000 diopters between eyes undergoing bilateral PRK surgery.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Nevanac

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

    Drug: nepafenac 0.1%

  • Placebo comparator
    Acular LS

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

    Other: ketorolac 0.4%

Interventions

  • Drugnepafenac 0.1%

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

  • Otherketorolac 0.4%

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

06

What researchers measure

Primary outcomes

  1. Subjective pain

    Time frame: Day 5

Secondary outcomes

  1. Rate of epithelial healing

    Time frame: Time to event

07

Study locations

1 site
  • Lackland Air Force Base
    San Antonio, Texas 78236, United States
08

References and documents

Publications

  • 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. PubMed 18500088 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00330798
Lead sponsor
Alcon Research
Collaborators
Matthew Caldwell
Responsible party
Sponsor
First posted
May 29, 2006
Start date
Feb 2006
Primary completion
Jun 2006
Completion
Jun 2006
Last update
Nov 18, 2016

Study contacts

Matthew Caldwell
principal investigator
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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