A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Op… (NCT01193231) | Clinical Trial Compass
CompletedNot Applicable
A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAILâ„¢ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
United States10 participantsStarted 2010-08
Plain-language 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
Who can participate
Age range18 Years – 39 Years
SexALL
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Inclusion criteria
✓. 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
. 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.