A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing

Overview

STUDY OBJECTIVE: To evaluate the safety and efficacy of Acuvail 0.45% administered BID for increasing corneal re-epithelialization, decreasing the time to zero pain in post-photorefractive keratectomy (PRK) surgery, and PRK enhancement assessment at 6 months post op CLINICAL HYPOTHESES: Acuvail 0.45% administered twice daily is superior to Systane Ultra lubricant in treating post PRK pain OVERAL STUDY DESIGN: Structure: Single-center, randomized, open label, contralateral (one eye receives Acuvail, one eye Systane Ultra) Treatment Group: Patients will be randomized to the eye that will receive Acuvail 0.45% Assignment: Acuvail 0.45% in one eye, Systane Ultra in contralateral eye Duration: 6.5 months Controls: Systane Ultra preservative-free lubricant Dosage/Dose Regimen: Study medication will be administered to the randomized eye through post op days 1-2 BID Visit Schedule: Screening (baseline), Day 2-30 (Surgery), post surgery Day 1 and each day through corneal re-epithelialization, post surgery months 1, 3, and 6. Number of Patients: 10 (20 eyes) Condition/Disease: patients undergoing bilateral PRK surgery

1. INTRODUCTION Laser Vision Correction is one of the most commonly performed elective procedures in the United States. Although the Laser in situ keratomileusis (LASIK) is the more popular vision correction procedure, a growing number of surgeons have switched to surface ablation techniques, including PRK, LASEK, and Epi-LASIK. In surface laser procedures, the epithelium (clear outer skin of the cornea) is removed, prior to laser reshaping of the cornea. This creates an epithelial defect that can take 3-6 days for the epithelium to regenerate. During this healing process, patients often report moderate to severe ocular pain. A variety of treatments have been utilized to reduce postoperative pain. Placement of a contact lens on the eye immediate post PRK, has been shown to reduce patient discomfort as well as topical dilute tetracaine, oral medications, and even prednisone has been recommended as treatment options for pain control. Another method that has been shown in a number of studies to assist with the reduction of post operative pain is topical non steroidal anti inflammatory drops. Pain management following PRK surgery has been minimized by more advanced surgical techniques, antibiotics, and pre- or post-operative use of topical NSAID solutions. We will compare the use of Acuvail 0.45% administered twice daily to Systane Ultra in treating post PRK pain. 2. STUDY OBJECTIVE To evaluate the safety and efficacy of Acuvail 0.45% administered BID for increasing re-epithelialization time, decreasing the time to zero pain in post-photorefractive keratectomy (PRK) surgery and assessment of PRK enhancement needs at 6 months post op. CLINICAL HYPOTHESES: Acuvail 0.45% administered twice daily is superior to Systane Ultra in treating post PRK pain Efficacy Objectives Primary: Time to re-epithelialization Secondary: Time to zero pain as documented in Patient Comfort Questionnaire PRK enhancement assessment at 6 month post op Safety Measures: Visual recovery-UCVA \& BCVA IOP Biomicroscopy Adverse Events Optovue OCT-epithelial image Pachymetry Pregnancy test 3. STUDY DESIGN This is a Phase 4, single-center, open label, randomized, contralateral (one eye receives Acuvail, one eye Systane Ultra Lubricant Eye Drops). Patients will be randomized to the eye that will receive Acuvail 0.45%. The duration of the study is estimated to be approximately 6.5 months for each study subject enrolled. Controls: Systane Ultra preservative free tears Dosage/Dose Regimen: Study medication will be administered twice a day to the randomized eye days 1-3 post operatively BID Visit Schedule: Screening (baseline), Day 2-30 (Surgery), post surgery Day 1, Day 2, Day 3, and each day through corneal re-epithelialization, post surgery months 1, 3, and 6. Number of Patients: 10- all subjects will use study medication in one eye, and Systane Ultra in the other eye Condition/Disease: patients undergoing bilateral PRK surgery Instructions for storage, use and administration Study medication and control medication should be stored in a secure area at room temperature and administered to patients entered in to the study in accordance to this protocol.