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

Completed

Conditions studied: Must be PRK Candidate

In brief

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

Key facts

Study ID

NCT01193231

Run by

Durrie Vision

People needed

10

Starts

2010-08-01

Expected to finish

2011-04-01

Last updated by the study team

2012-02-14

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Females of childbearing potiential must have a negative pregnancy test result at baseline. A female considered to be of non-childbearing potential is she is postmenopausal (no menses for 12 consecutive months) or is without a uterus.
• Ability to follow study instructions and likely to complete the entire course of the study
• Written informed consent has been obtained
• Written HIPPA authorization has been obtained

You may not qualify if…

• Uncontrolled systemic disease
• Any active ocular disease, corneal abnormalities, lid abnormalities, or any ocular pathologies
• History of serious eye disease, trauma, or previous ocular surgery
• History of unstable myopia
• History of herpes keratitis
• Known allergy or hypersensitivity to the study medication
• Anticipated wearing of contact lenses in addition to the required bandage contact lens post-PRK. Patients who wear soft contact lenses should discontinue wearing them at least 3 days prior to baseline visit. Patients wearing RGP or hard contact lenses should discontinue wearing them at least 3 weeks prior to baseline visit.
• Females who are pregnant, breastfeeding, or trying to conceive.
• Keratoconus or keratoconus suspect
• Concurrent participation in an investigational drug study or participation within 30 days prior to study start
• Any condition or situation which, in the investigator's opinion, may put patient at significant risk or may confound the study results

Where it is running

• Durrie Vision — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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