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

Summary: 
      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
    

Detailed description: 
      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.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male or female patients, 18-39 yrs of age, in good general health Patient is schedule to
        undergo bilateral PRK surgery The difference between the two eyes ≤ 2 D Refractive error -1
        to -8 diopters (spherical equivalent) at baseline
      
Keywords: Laser Vision Correction; Photorefractive Keratectomy; PRK; Nearsighted; Myopia