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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02974387
Recruitment Status : Unknown
Verified November 2016 by Dr Salouti Eye Research Center.
Recruitment status was:  Not yet recruiting
First Posted : November 28, 2016
Last Update Posted : November 28, 2016
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Must be PRK Candidate Drug: Fluorometholone(FML) Drug: Loteprednol (Lotemax) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. Time to re-epithelialization [ Time Frame: 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 :
  1. Time to zero pain [ Time Frame: 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.

  2. Occurrence of enhancements [ Time Frame: 3 months post operative ]
    Will document the number of requested/recommended enhancement procedures at the 3 month postoperative visit.

  3. Incidence of adverse events [ Time Frame: Day 1 up to day 90 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02974387

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Contact: Payam Peymani, Pharm.D, PhD
Contact: Mohammadreza Razeghinejad, M.D., Ophthalmologist

Sponsors and Collaborators
Dr Salouti Eye Research Center
Shiraz University of Medical Sciences

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Responsible Party: Dr Salouti Eye Research Center Identifier: NCT02974387     History of Changes
Other Study ID Numbers: SERCCT1
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Loteprednol Etabonate
Anti-Allergic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs