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

NCT01193231 | Completed

• 1 other identifier: ACVL-001
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 (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

Conditions

Must be PRK Candidate

Keywords

Laser Vision Correction; Photorefractive Keratectomy; PRK; Nearsighted; Myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to zero pain

  3-7 days

• Occurence of enhancments

  6 months post operative

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Durrie Vision: lead
• Allergan: collaborator

Study Sites (1)

Durrie Vision

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Daniel S. Durrie, MD

  Durrie Vision

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Presidenet

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 1, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

US (1)