| Eligibility |
Inclusion Criteria:
1. Patients = 22 years of age at time of surgery
2. patients who have been cleared to undergo PRK procedure
3. Patients who are willing to have procedure in both eyes, at least 1 week apart
randomized to receive the product under investigation in one eye and control lens in
other eye
4. Patients are able to wear bandage contact lens for 1 week
5. Patients able to attend all follow-up study visits
Exclusion Criteria:
1. Patients who have experienced complications during PRK procedures
2. Women of childbearing potential that are pregnant, nursing, or planning a pregnancy,
and are not using effective methods of contraception. Effective contraception methods
include:
1. Total abstinence (when this is in line with the preferred and usual lifestyle of
the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post
ovulation methods) and withdrawal are not acceptable methods of contraception.
(Occasional abstinence is not an effective contraceptive method).
2. Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy) or tubal ligation at least 6 weeks before Baseline. In case of
oophorectomy alone, only when the reproductive status of the woman has been
confirmed by follow up hormone level assessment
3. Male sterilization (at least 6 months prior to Baseline). For female subjects in
the study, the vasectomized male partner should be the sole partner for that
subject
4. Barrier methods of contraception: condom or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
5. Use of oral, injected or implanted hormonal methods of contraception or other
forms of hormonal contraception that have comparable efficacy (failure rate <
1%), for example hormone vaginal ring or transdermal hormone contraception
6. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
3. Known allergy to Tetracaine or contraindications for its use
4. Significant anisometropia of greater than 2 diopters of manifest refraction spherical
equivalent (MRSE) between eyes or hyperopes
5. Subjects having a history of previous eye surgery
6. Subjects with planned MRSE treatment of greater than 6.00D
7. Subjects with uncontrolled dry eye disease in the opinion of the investigator
8. History of systemic disorder such as diabetes, connective tissue disorder (systemic
lupus erythematosis, rheumatoid arthritis, Sjögren syndrome, mucous membrane
pemphigoid), thyroid disease, or immunosuppressive disorders (Human Immunodeficiency
Virus [HIV], long-term steroid use, transplant recipient), that may affect
post-operative healing
9. Corneal disease that may affect outcomes including keratoconus, form fruste
keratoconus, limbal stem cell deficiency, pellucid marginal degeneration, contact lens
warpage, and/or herpes keratitis
10. Use of chronic glaucoma and or hypotensive topical medications than in the view of the
investigator could cause epitheliopathy and affect the rate of re-epithelization
11. Visually significant cataract
12. Other pathology of the cornea or anterior segment including lagophthalmos,
blepharitis, anterior membrane dystrophy, corneal neuropathy, recurrent erosions
and/or scarring that would affect wound re-epithelization
13. Use of medications that may affect and/or decrease the rate of corneal healing [e.g.,
systemic and or topical medications (corticosteroids, antimetabolites such as
mitomycin) and/or antiviral medications] and or recent use (within the past 6 months)
of isotretinoin, amiodarone or any medications that can affect corneal integrity
14. Any other factors that in the opinion of the investigator could put the subject at
safety risk
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