A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief
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ClinicalTrials.gov Identifier: NCT00330798 |
Recruitment Status :
Completed
First Posted : May 29, 2006
Last Update Posted : November 18, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Photorefractive Keratectomy | Drug: nepafenac 0.1% Other: ketorolac 0.4% | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief of Patients Status Post-Photorefractive Keratectomy: A Double-Masked Randomized Prospective Study |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Nevanac
One drop, three times daily, in the assigned eye for the first three postoperative days
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Drug: nepafenac 0.1%
Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use. |
Placebo Comparator: Acular LS
One drop, three times daily, in the assigned eye for the first three postoperative days
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Other: ketorolac 0.4%
Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use. |
- Subjective pain [ Time Frame: Day 5 ]
- Rate of epithelial healing [ Time Frame: Time to event ]

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330798
United States, Texas | |
Lackland Air Force Base | |
San Antonio, Texas, United States, 78236 |
Principal Investigator: | Matthew Caldwell |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00330798 |
Other Study ID Numbers: |
FWH20060020H |
First Posted: | May 29, 2006 Key Record Dates |
Last Update Posted: | November 18, 2016 |
Last Verified: | May 2012 |
Photorefractive Keratectomy |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Ketorolac Nepafenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |