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

This is an interventional treatment trial for Must be PRK Candidate Read More

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.