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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

NCT01193231 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2012-02-14

No results posted yet for this study

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

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Durrie Vision

    lead OTHER

Principal Investigators

  • Daniel S. Durrie, MD · Durrie Vision

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-03-31
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193231 on ClinicalTrials.gov