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| Sponsor: | Center For Excellence In Eye Care |
|---|---|
| Collaborator: |
Allergan |
| Information provided by: | Center For Excellence In Eye Care |
| ClinicalTrials.gov Identifier: | NCT00347204 |
Purpose
To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS & Nevanac) to help control pain following Photorefractive Keratectomy (PRK).
| Condition | Intervention | Phase |
|---|---|---|
|
Myopia Hyperopia |
Drug: ketorolac (Acular LS) Drug: Nepafenac (Nevanac) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | June 2006 |
Laser Vision Correction is the most commonly performed elective surgical procedure in the United States. Although Laser-Assisted in-situ Keratomileusis (LASIK) is the more popular technique, a growing number of surgeons have switched to surface ablation techniques, including PRK, LASEK and Epi-LASIK.1 With surface laser procedures, the corneal epithelium is removed by a variety of techniques (laser, manual debridement, diluted alcohol2,3, epi-keatome) prior to laser reshaping of the corneal stroma. Following the procedure, a contact lens is placed on the eye to promote epithelial regeneration. Due to the size of the epithelial defect, it can take between 3 to 6 days for the epithelium to regenerate. During this healing process, patients often complain of moderate to severe ocular pain, and delayed healing may result in an increased risk of infection or corneal haze4.
Over the past decade, a variety of methods have been used to assist with reducing pain following surface laser procedures. Topical Nonsteroidals have been shown in a number of studies to help reduce the degree of pain following PRK. Topical dilute tetracaine has also been shown to assist with the reduction of pain following PRK. Oral pain medications, such as Vioxx, Celebrex, and even Prednisone have been recommended as additional treatment options for pain control.
In October 2005, a new topical nonsteroidal anti-inflammatory drop, Nevanac, was approved by the FDA. Nevanac was approved with a a TID dosing schedule.
Acular LS is the current market leader for topical NSAID eye drops. Acular LS is typically used on a QID dosing schedule.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
-
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00347204 History of Changes |
| Obsolete Identifiers: | NCT00405028 |
| Other Study ID Numbers: | 5225 |
| Study First Received: | June 29, 2006 |
| Last Updated: | June 29, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
PRK laser vision correction surface ablation |
pain wound healing corneal haze |
|
Hyperopia Myopia Refractive Errors Eye Diseases Ketorolac Ketorolac Tromethamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
