Must be PRK Candidate Clinical Trial
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 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).
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | November 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr Salouti Eye Research Center | Shiraz University of Medical Sciences |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to re-epithelialization | Amount of days it takes for the cornea to re-epithelialize after PRK surgery, will be documented for each eye separately. | 3-7 days | No |
Secondary | Time to zero pain | 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. | 3-7 days | No |
Secondary | Occurrence of enhancements | Will document the number of requested/recommended enhancement procedures at the 3 month postoperative visit. | 3 months post operative | No |
Secondary | Incidence of adverse events | Day 1 up to day 90 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01193231 -
A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
|
N/A |