Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Fluorometholone(FMl) Patients will be randomized to the eye and will receive FML in one eye. |
Drug: Fluorometholone(FML)
|
| Active Comparator: Loteprednol (Lotemax) Patients will be randomized to the eye and will receive Lotemax in contralateral eye. |
Drug: Loteprednol (Lotemax)
|
Outcome Measures
Primary Outcome Measures
- Time to re-epithelialization [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 Outcome Measures
- Time to zero pain [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 [3 months post operative]
Will document the number of requested/recommended enhancement procedures at the 3 month postoperative visit.
- Incidence of adverse events [Day 1 up to day 90]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients, 18-45 yrs of age, in good general health
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PRK candidate(Subjects willing and able to undergo bilateral PRK for the correction of their myopia. )
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Refractive error -1 to -8 diopters (spherical equivalent) at baseline
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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.
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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. )
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Written informed consent will be obtained
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Written HIPPA authorization will be obtained
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Subjects with MRSE <6.0 D, with less than 2.0 D of astigmatism.
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Stable prescription in both eyes as defined by <0.25 D change over the preceding 2 years.
Exclusion Criteria:
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Uncontrolled systemic disease you mean if someone has controlled DM or rheumatic disease can be included
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Any active ocular disease, corneal abnormalities, lid abnormalities, or any ocular pathologies
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History of serious eye disease, trauma, or previous ocular surgery
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History of unstable myopia
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History of herpes keratitis
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Known allergy or hypersensitivity to the study medication
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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.
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Females who are pregnant, breastfeeding, or trying to conceive.
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Keratoconus or keratoconus suspect
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Any condition or situation which, in the investigator's opinion, may put patient at significant risk or may confound the study results
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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.
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Subjects who have previously had corneal surgery.
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Subjects with any ocular disease or corneal abnormality, including but not limited to:
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Decreased corneal sensation / neurotrophic cornea;
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Corneal vascularization;
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Keratoconus;
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Keratoconjunctivitis sicca requiring chronic treatment;
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Lagophthalmos;
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Blepharitis;
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History of infectious keratitis;
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History of glaucoma or intraocular pressure of >21 mmHg or use of glaucoma medications;
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Significant dry eye disease that requires regular topical treatment;
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Corneal thickness <480 µm at the thinnest point, and
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Posterior elevation >40 micron.
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Subjects who require any topical ophthalmic medication other than the pre- and postoperative regimen defined in the study protocol.
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Subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine, scopolamine, or medications or agents that can cause dry eye.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Dr Salouti Eye Research Center
- Shiraz University of Medical Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SERCCT1