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

Dr Salouti Eye Research Center

Status and phase: Unknown; Phase 4

Conditions: Must be PRK Candidate

Treatments: Drug: Fluorometholone(FML); Drug: Loteprednol (Lotemax)

Study type: Interventional

Funder types: Other

Identifiers

NCT02974387

SERCCT1

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Fluorometholone(FMl)

Active Comparator group

Description:

Patients will be randomized to the eye and will receive FML in one eye.

Treatment:

Drug: Fluorometholone(FML)

Loteprednol (Lotemax)

Active Comparator group

Description:

Patients will be randomized to the eye and will receive Lotemax in contralateral eye.

Treatment:

Drug: Loteprednol (Lotemax)