Lacripep for Corneal Wound Healing Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-55
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 0.00025% Lacripep ophthalmic solution and Placebo

Treatment groups

88 Participants
are divided into 1 treatment group

Sponsors and collaborators

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead sponsor

TearSolutions, Inc.

Collaborator

Walter Reed National Military Medical Center

Collaborator