Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
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|ClinicalTrials.gov Identifier: NCT02974387|
Recruitment Status : Not yet recruiting
First Posted : November 28, 2016
Last Update Posted : November 28, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Must be PRK Candidate||Drug: Fluorometholone(FML) Drug: Loteprednol (Lotemax)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||April 2017|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||November 2017|
Active Comparator: Fluorometholone(FMl)
Patients will be randomized to the eye and will receive FML in one eye.
Active Comparator: Loteprednol (Lotemax)
Patients will be randomized to the eye and will receive Lotemax in contralateral eye.
Drug: Loteprednol (Lotemax)
- 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 3-7 days post op exam.
- Occurrence of enhancements [ Time Frame: 3 months post operative ]Will document the number of requested/recommended enhancement procedures at the 3 month postoperative visit.
- Incidence of adverse events [ Time Frame: Day 1 up to day 90 ]
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): NCT02974387
|Contact: Payam Peymani, Pharm.D, PhDfirstname.lastname@example.org|
|Contact: Mohammadreza Razeghinejad, M.D., Ophthalmologistemail@example.com|