Lacripep for Corneal Abrasion

Overseen By Thomas Jenkins

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Must not be taking: Corticosteroids, Antimetabolites, Accutane, Cordarone

Disqualifiers: Pregnancy, Dry eye, Keratoconus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6 months

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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).

Who Is on the Research Team?

Zachary P Skurski, DO

Principal Investigator

Alexander T. Augusta Military Medical Center

Are You a Good Fit for This Trial?

This trial is for U.S. military service members aged 21 or older seeking refractive correction for mild to moderate myopia, with stable vision over the past year and good eye health. Participants must be able to attend follow-ups for up to six months after PRK surgery.

Inclusion Criteria

I have chosen to have PRK surgery on both eyes.

I am an active-duty U.S. military member eligible for care.

I have 20/20 vision in both eyes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lacripep in one eye and placebo in the other eye for corneal wound healing

6 months

Visits at 4 and 7 days, then at 1, 3, and 6 months postoperatively

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lacripep

Trial Overview The study tests Lacripep ophthalmic solution's safety and effectiveness in healing superficial corneal injuries post-PRK surgery compared to a placebo. It aims to improve recovery outcomes for those with unintentional home injuries like corneal abrasions.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Participants will receive Lacripep in one eye and placebo in the other eye at the same time.

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

TearSolutions, Inc.

Industry Sponsor

Trials

2

Recruited

290+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+