Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild t… (NCT02974387) | Clinical Trial Compass
UnknownPhase 4
Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
200 participantsStarted 2017-04
Plain-language summary
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).
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female patients, 18-45 yrs of age, in good general health
* PRK candidate(Subjects willing and able to undergo bilateral PRK for the correction of their myopia. )
* Refractive error -1 to -8 diopters (spherical equivalent) at baseline
* Females of childbearing age 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(Subjects who are able to comply with all study procedures, including wearing a soft bandage contact lens in the immediate postoperative period. )
* Written informed consent will be obtained
* Written HIPPA authorization will be obtained
* Subjects with MRSE \<6.0 D, with less than 2.0 D of astigmatism.
* Stable prescription in both eyes as defined by \<0.25 D change over the preceding 2 years.
Exclusion Criteria:
* Uncontrolled systemic disease you mean if someone has controlled DM or rheumatic disease can be included
* 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. Pa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.