Clinical Drug Experience Knowledgebase

Criteria

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.