Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
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
1 other identifier
interventional
200
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2017
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2016
CompletedFirst Posted
Study publicly available on registry
November 28, 2016
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedNovember 28, 2016
November 1, 2016
4 months
November 16, 2016
November 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time to re-epithelialization
Amount of days it takes for the cornea to re-epithelialize after PRK surgery, will be documented for each eye separately.
3-7 days
Secondary Outcomes (3)
Time to zero pain
3-7 days
Occurrence of enhancements
3 months post operative
Incidence of adverse events
Day 1 up to day 90
Study Arms (2)
Fluorometholone(FMl)
ACTIVE COMPARATORPatients will be randomized to the eye and will receive FML in one eye.
Loteprednol (Lotemax)
ACTIVE COMPARATORPatients will be randomized to the eye and will receive Lotemax in contralateral eye.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2016
First Posted
November 28, 2016
Study Start
April 1, 2017
Primary Completion
August 1, 2017
Study Completion
November 1, 2017
Last Updated
November 28, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share