Status:
COMPLETED
A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
Lead Sponsor:
Durrie Vision
Collaborating Sponsors:
Allergan
Conditions:
Must be PRK Candidate
Eligibility:
All Genders
18-39 years
Brief Summary
STUDY OBJECTIVE: To evaluate the safety and efficacy of Acuvail 0.45% administered BID for increasing corneal re-epithelialization, decreasing the time to zero pain in post-photorefractive keratectomy...
Detailed Description
1. INTRODUCTION Laser Vision Correction is one of the most commonly performed elective procedures in the United States. Although the Laser in situ keratomileusis (LASIK) is the more popular vision...
Eligibility Criteria
Inclusion
- Male or female patients, 18-39 yrs of age, in good general health
- Patient is schedule to undergo bilateral PRK surgery
- The difference between the two eyes ≤ 2 D
- Refractive error -1 to -8 diopters (spherical equivalent) at baseline
- Females of childbearing potiential 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
- Written informed consent has been obtained
- Written HIPPA authorization has been obtained
Exclusion
- Uncontrolled systemic disease
- 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 3 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
- Concurrent participation in an investigational drug study or participation within 30 days prior to study start
- Any condition or situation which, in the investigator's opinion, may put patient at significant risk or may confound the study results
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01193231
Start Date
August 1 2010
End Date
April 1 2011
Last Update
February 14 2012
Active Locations (1)
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1
Durrie Vision
Overland Park, Kansas, United States, 66211