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A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Daniel S. Durrie, MD, Durrie Vision
ClinicalTrials.gov Identifier:
NCT01193231
First received: August 31, 2010
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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


Condition
Must be PRK Candidate

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Single Center, Randomized, Contralateral, 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing

Resource links provided by NLM:


Further study details as provided by Durrie Vision:

Primary Outcome Measures:
  • Time to re-epithelialization [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]
    Amount of days it takes for the cornea to re-epithelialize after PRK surgery, will be documented for each eye separately.


Secondary Outcome Measures:
  • Time to zero pain [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]
    Study subject will complete a questionnaire about their comfort levels at each postoperative visit, up to an including the 6 month post op exam.

  • Occurence of enhancments [ Time Frame: 6 months post operative ] [ Designated as safety issue: No ]
    Will document the number of requested/recommended enhancement procedures at the 6 month postoperativ visit.


Enrollment: 10
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acuvail 0.45%
Each subject will be randomized to the eye that they will use Acuvail in for 3 days after PRK
Systane Ultra Preservative Free Tears
Each subject's contralateral eye (other eye) will use Sytane for 3 days after PRK surgery.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193231

Locations
United States, Kansas
Durrie Vision
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Durrie Vision
Allergan
Investigators
Principal Investigator: Daniel S. Durrie, MD Durrie Vision
  More Information

No publications provided

Responsible Party: Daniel S. Durrie, MD, Presidenet, Durrie Vision
ClinicalTrials.gov Identifier: NCT01193231     History of Changes
Other Study ID Numbers: ACVL-001
Study First Received: August 31, 2010
Last Updated: February 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Durrie Vision:
Laser Vision Correction
Photorefractive Keratectomy
PRK
Nearsighted
Myopia

Additional relevant MeSH terms:
Analgesics
Ketorolac
Ketorolac Tromethamine
Ophthalmic Solutions
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014