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).
Male or female, of any race, 21 years old and older
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
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
Stable refraction for the past year as demonstrated by a change in manifest refractive spherical equivalent of ≤ 0.50 diopters (D) in both eyes
Calculated ablation depth of greater than 75 microns or other conditions in either eye which in the judgement of the investigators will require use of prophylactic MMC
Signs of unstable or progressive myopia, keratoconus or keratoconus suspect in either eye
Abnormal corneal topographic findings in either eye e.g., keratoconus, pellucid marginal degeneration
Treatment targeted for monovision
Single group
0.00025% Lacripep ophthalmic solution and Placebo
DrugParticipant will receive Lacripep in one eye and placebo in the other eye at the same time.
Efficacy of Lacripep
To determine the efficacy of Lacripep for corneal wound healing, epithelial thickness will be be measured using optical coherence tomography (OCT). OCT is a non-invasive imaging technique that uses light waves to create detailed images of tissue structures.
Lacripep safety
To determine the safety of Lacripep, the return of corrected distance visual acuity (CDVA) will be measured using high contrast visual acuity test. Return of CDVA will be defined as percentage of eyes with no more than 1 CDVA line lost from preoperative baseline.
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Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead sponsor
TearSolutions, Inc.
Collaborator
Walter Reed National Military Medical Center
Collaborator
