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

Must be PRK Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02974387
• Other study ID #: SERCCT1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 16, 2016
• Last updated: November 22, 2016
• Start date: April 2017
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: Dr Salouti Eye Research Center
• Contact: Payam Peymani, Pharm.D, PhD
• Email: peymani.payam[@]gmail.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Must be PRK Candidate

Intervention

Drug:
• Fluorometholone(FML)

• Loteprednol (Lotemax)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr Salouti Eye Research Center	Shiraz University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Occurrence of enhancements	Will document the number of requested/recommended enhancement procedures at the 3 month postoperative visit.	3 months post operative	No
Secondary	Incidence of adverse events		Day 1 up to day 90	Yes