Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
NCT ID: NCT02974387
Last Updated: 2016-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2017-04-30
2017-11-30
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fluorometholone(FMl)
Patients will be randomized to the eye and will receive FML in one eye.
Fluorometholone(FML)
Loteprednol (Lotemax)
Patients will be randomized to the eye and will receive Lotemax in contralateral eye.
Loteprednol (Lotemax)
Interventions
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Fluorometholone(FML)
Loteprednol (Lotemax)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Shiraz University of Medical Sciences
OTHER
Dr Salouti Eye Research Center
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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SERCCT1
Identifier Type: -
Identifier Source: org_study_id