Must be PRK Candidate Clinical Trial
Official title:
Randomized, Single Blinded Controlled Trial for Evaluation of the Safety and Efficacy of Loteprednol Versus Fluorometholone After Photorefractive Keratectomy for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
STUDY OBJECTIVE: To evaluate and compare the safety and efficacy of (corneal Wound Healing
and Intraocular Pressure) Fluorometholone and Loteprednol after photorefractive keratectomy
(PRK) surgery.
OVERALL STUDY DESIGN: Structure: Single-center, randomized, single blinded, contralateral
(one eye receives FML, one eye Lotemax) Treatment Group: Patients will be randomized to the
eye and will receive FML in one eye, Lotemax in contralateral eye Duration: 3 months
Dosage/Dose Regimen: All patients will receive each one of the steroid agents 4 x a day for
one month, 3 x a day for one month and 2 x a day for one month Study medication will be
administered to the randomized eye through post op days according to mention protocol. Visit
Schedule: baseline-screening, postop days 1, 7, 30 and then month 3th (through corneal
re-epithelialization).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01193231 -
A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
|
N/A |