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 range18 Years – 45 Years
SexALL
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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…