Lacripep, a Novel Investigational Agent, for Corneal Wound Healing and Ocular Surface Homeostasis
Henry M. Jackson Foundation for the Advancement of Military Medicine
Summary
The objective of this study is to evaluate the safety and effectiveness of Lacripep as a therapy for superficial corneal injury repair after Photorefractive keratectomy (PRK).
Description
The purpose of this study is to assess the effect of an eyedrop medication, Lacripep, on wound healing in the cornea (the transparent tissue covering the front of the eye) such as seen after incidental or combat related trauma, or from eye surgeries like Photorefractive keratectomy (PRK). This study will help understand if Lacripep is an effective treatment in ocular surface healing and speeding visual recovery after injury. Participants must be an active-duty service member or a dependent eligible for care at a military treatment facility.
Eligibility
- Age range
- 21–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female, of any race, 21 years old and older 2. Active-duty U.S. military service members or their dependents eligible for care at Alexander T. Augusta Military Medical Center for 6-month period postoperatively 3. Desiring refractive correction of myopia up to -4.00 diopters (D) sphere with or without astigmatism 0 to -1.50 D and up to -4.00 D manifest spherical equivalent in both eyes 4. Stable refraction for the past year as demonstrated by a change in manifest refractive spherical equivalent of ≤ 0.50 diopters (D) in both eyes 5. CDVA of at least 20/20 in both…
Interventions
- Drug0.00025% Lacripep ophthalmic solution and Placebo
Participant will receive Lacripep in one eye and placebo in the other eye at the same time.
Location
- Alexander T. Augusta Military Medical CenterFort Belvoir, Virginia