Must be PRK Candidate Clinical Trial
Official title:
A Single Center, Randomized, Contralateral, 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAILâ„¢ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
Verified date | February 2012 |
Source | Durrie Vision |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 (PRK) surgery, and PRK enhancement assessment at 6 months
post op
CLINICAL HYPOTHESES: Acuvail 0.45% administered twice daily is superior to Systane Ultra
lubricant in treating post PRK pain
OVERAL STUDY DESIGN:
Structure: Single-center, randomized, open label, contralateral (one eye receives Acuvail,
one eye Systane Ultra)
Treatment Group: Patients will be randomized to the eye that will receive Acuvail 0.45%
Assignment: Acuvail 0.45% in one eye, Systane Ultra in contralateral eye
Duration: 6.5 months
Controls: Systane Ultra preservative-free lubricant
Dosage/Dose Regimen: Study medication will be administered to the randomized eye through post
op days 1-2 BID
Visit Schedule: Screening (baseline), Day 2-30 (Surgery), post surgery Day 1 and each day
through corneal re-epithelialization, post surgery months 1, 3, and 6.
Number of Patients: 10 (20 eyes)
Condition/Disease: patients undergoing bilateral PRK surgery
Status | Completed |
Enrollment | 10 |
Est. completion date | April 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion Criteria: 1. Male or female patients, 18-39 yrs of age, in good general health 2. Patient is schedule to undergo bilateral PRK surgery 3. The difference between the two eyes = 2 D 4. Refractive error -1 to -8 diopters (spherical equivalent) at baseline 5. 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. 6. Ability to follow study instructions and likely to complete the entire course of the study 7. Written informed consent has been obtained 8. Written HIPPA authorization has been obtained Exclusion Criteria: 1. Uncontrolled systemic disease 2. Any active ocular disease, corneal abnormalities, lid abnormalities, or any ocular pathologies 3. History of serious eye disease, trauma, or previous ocular surgery 4. History of unstable myopia 5. History of herpes keratitis 6. Known allergy or hypersensitivity to the study medication 7. 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. 8. Females who are pregnant, breastfeeding, or trying to conceive. 9. Keratoconus or keratoconus suspect 10. Concurrent participation in an investigational drug study or participation within 30 days prior to study start 11. Any condition or situation which, in the investigator's opinion, may put patient at significant risk or may confound the study results |
Country | Name | City | State |
---|---|---|---|
United States | Durrie Vision | Overland Park | Kansas |
Lead Sponsor | Collaborator |
---|---|
Durrie Vision | Allergan |
United States,
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 | |
Secondary | Time to zero pain | Study subject will complete a questionnaire about their comfort levels at each postoperative visit, up to an including the 6 month post op exam. | 3-7 days | |
Secondary | Occurence of enhancments | Will document the number of requested/recommended enhancement procedures at the 6 month postoperativ visit. | 6 months post operative |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02974387 -
Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
|
Phase 4 |