A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
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|ClinicalTrials.gov Identifier: NCT01193231|
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : February 14, 2012
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
|Condition or disease|
|Must be PRK Candidate|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|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|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||April 2011|
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.
- Time to re-epithelialization [ Time Frame: 3-7 days ]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 ]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 ]Will document the number of requested/recommended enhancement procedures at the 6 month postoperativ visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193231
|United States, Kansas|
|Overland Park, Kansas, United States, 66211|
|Principal Investigator:||Daniel S. Durrie, MD||Durrie Vision|