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

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 Overview

• Status: Unknown
• Conditions: Must be PRK Candidate
• Intervention / Treatment: Drug: Fluorometholone(FML); Drug: Loteprednol (Lotemax)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Payam Peymani, Pharm.D, PhD; Email: peymani.payam@gmail.com
• Study Contact Backup: Name: Mohammadreza Razeghinejad, M.D., Ophthalmologist; Email: razeghinejad@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to zero pain	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.	3-7 days
Occurrence of enhancements	Will document the number of requested/recommended enhancement procedures at the 3 month postoperative visit.	3 months post operative
Incidence of adverse events		Day 1 up to day 90

Collaborators and Investigators

• Sponsor: Dr Salouti Eye Research Center
• Collaborators: Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2017
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 28, 2016

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Loteprednol Etabonate; Fluorometholone
• Other Study ID Numbers: SERCCT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No