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

NCT01193231 COMPLETED

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

Details

Lead sponsor	Durrie Vision
Status	COMPLETED
Enrolment	10
Start date	2010-08
Completion	2011-04

Conditions

• Must be PRK Candidate

Primary outcomes

• Time to re-epithelialization — 3-7 days
  Amount of days it takes for the cornea to re-epithelialize after PRK surgery, will be documented for each eye separately.

Countries

United States