Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study

Phase 4

• Conditions: Must be PRK Candidate
• Interventions: Drug: Loteprednol (Lotemax); Drug: Fluorometholone(FML)

• Registration Number: NCT02974387
• Lead Sponsor: Dr Salouti Eye Research Center

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-22
• Last Update Submitted: 2016-11-22
• Study First Posted: 2016-11-28
• Last Update Posted: 2016-11-28
• Study Start: 2017-04
• Primary Completion: 2017-08
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol (Lotemax)	Loteprednol (Lotemax)	Patients will be randomized to the eye and will receive Lotemax in contralateral eye.
Fluorometholone(FMl)	Fluorometholone(FML)	Patients will be randomized to the eye and will receive FML in one eye.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.