A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
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
Must be PRK Candidate
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Single Center, Randomized, Contralateral, 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing|
- Time to re-epithelialization [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]Amount of days it takes for the cornea to re-epithelialize after PRK surgery, will be documented for each eye separately.
- Time to zero pain [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]Study subject will complete a questionnaire about their comfort levels at each postoperative visit, up to an including the 6 month post op exam.
- Occurence of enhancments [ Time Frame: 6 months post operative ] [ Designated as safety issue: No ]Will document the number of requested/recommended enhancement procedures at the 6 month postoperativ visit.
|Study Start Date:||August 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Each subject will be randomized to the eye that they will use Acuvail in for 3 days after PRK
Systane Ultra Preservative Free Tears
Each subject's contralateral eye (other eye) will use Sytane for 3 days after PRK surgery.
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