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
Overview
- Phase
- Phase 4
- Intervention
- Fluorometholone(FML)
- Conditions
- Must be PRK Candidate
- Sponsor
- Dr Salouti Eye Research Center
- Enrollment
- 200
- Primary Endpoint
- Time to re-epithelialization
- Last Updated
- 9 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
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. Patients who wear soft contact lenses should discontinue wearing them at least 7 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.
- •Keratoconus or keratoconus suspect
- •Any condition or situation which, in the investigator's opinion, may put patient at significant risk or may confound the study results
Arms & Interventions
Fluorometholone(FMl)
Patients will be randomized to the eye and will receive FML in one eye.
Intervention: Fluorometholone(FML)
Loteprednol (Lotemax)
Patients will be randomized to the eye and will receive Lotemax in contralateral eye.
Intervention: Loteprednol (Lotemax)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Occurrence of enhancements(3 months post operative)
- Incidence of adverse events(Day 1 up to day 90)
- Time to zero pain(3-7 days)