Must be PRK Candidate Clinical Trial
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
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
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 correction procedure, a growing number of surgeons have switched to surface
ablation techniques, including PRK, LASEK, and Epi-LASIK. In surface laser procedures,
the epithelium (clear outer skin of the cornea) is removed, prior to laser reshaping of
the cornea. This creates an epithelial defect that can take 3-6 days for the epithelium
to regenerate. During this healing process, patients often report moderate to severe
ocular pain.
A variety of treatments have been utilized to reduce postoperative pain. Placement of a
contact lens on the eye immediate post PRK, has been shown to reduce patient discomfort
as well as topical dilute tetracaine, oral medications, and even prednisone has been
recommended as treatment options for pain control. Another method that has been shown in
a number of studies to assist with the reduction of post operative pain is topical non
steroidal anti inflammatory drops.
Pain management following PRK surgery has been minimized by more advanced surgical
techniques, antibiotics, and pre- or post-operative use of topical NSAID solutions. We
will compare the use of Acuvail 0.45% administered twice daily to Systane Ultra in
treating post PRK pain.
2. STUDY OBJECTIVE
To evaluate the safety and efficacy of Acuvail 0.45% administered BID for increasing
re-epithelialization time, decreasing the time to zero pain in post-photorefractive
keratectomy (PRK) surgery and assessment of PRK enhancement needs at 6 months post op.
CLINICAL HYPOTHESES: Acuvail 0.45% administered twice daily is superior to Systane Ultra
in treating post PRK pain
Efficacy Objectives
Primary: Time to re-epithelialization Secondary: Time to zero pain as documented in
Patient Comfort Questionnaire PRK enhancement assessment at 6 month post op
Safety Measures: Visual recovery-UCVA & BCVA IOP Biomicroscopy Adverse Events Optovue
OCT-epithelial image Pachymetry Pregnancy test
3. STUDY DESIGN
This is a Phase 4, single-center, open label, randomized, contralateral (one eye receives
Acuvail, one eye Systane Ultra Lubricant Eye Drops). Patients will be randomized to the eye
that will receive Acuvail 0.45%. The duration of the study is estimated to be approximately
6.5 months for each study subject enrolled.
Controls: Systane Ultra preservative free tears
Dosage/Dose Regimen: Study medication will be administered twice a day to the randomized eye
days 1-3 post operatively BID
Visit Schedule: Screening (baseline), Day 2-30 (Surgery), post surgery Day 1, Day 2, Day 3,
and each day through corneal re-epithelialization, post surgery months 1, 3, and 6.
Number of Patients: 10- all subjects will use study medication in one eye, and Systane Ultra
in the other eye
Condition/Disease: patients undergoing bilateral PRK surgery
Instructions for storage, use and administration Study medication and control medication
should be stored in a secure area at room temperature and administered to patients entered in
to the study in accordance to this protocol.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
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