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
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 200
- Primary Endpoint
- Time to re-epithelialization
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Subjects who have a past or present disease, which as judged by the investigator may affect the safety of the subject or the outcome of the study.
- •Subjects who have previously had corneal surgery.
- •Subjects with any ocular disease or corneal abnormality, including but not limited to:
- •Decreased corneal sensation / neurotrophic cornea;
- •Corneal vascularization;
- •Keratoconus;
- •Keratoconjunctivitis sicca requiring chronic treatment;
- •Lagophthalmos;
- •Blepharitis;
- •History of infectious keratitis;
- •History of glaucoma or intraocular pressure of >21 mmHg or use of glaucoma medications;
- •Significant dry eye disease that requires regular topical treatment;
- •Corneal thickness <480 µm at the thinnest point, and
- •Posterior elevation >40 micron.
- •Subjects who require any topical ophthalmic medication other than the pre- and postoperative regimen defined in the study protocol.
- •Subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine, scopolamine, or medications or agents that can cause dry eye.
Arms & Interventions
Fluorometholone(FMl)
Patients will be randomized to the eye and will receive FML in one eye.
Intervention: Fluorometholone(FML) (Drug)
Loteprednol (Lotemax)
Patients will be randomized to the eye and will receive Lotemax in contralateral eye.
Intervention: Loteprednol (Lotemax) (Drug)
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)