Recruiting
Phase 2

Lacripep

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT06854393

Conditions

Corneal Epithelial Wound Healing

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Not accepted

Interventions

0.00025% Lacripep ophthalmic solution and Placebo

Study Details

Brief 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).

Conditions

Corneal Epithelial Wound Healing

Study ID

NCT06854393

Start date

May 23, 2025

Status verified date

Sep, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Not accepted

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 eyes
6. Elected to undergo bilateral PRK
7. Able to meet follow up requirements for up to 6-month period post-operatively

Exclusion Criteria:

1. 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
2. Signs of unstable or progressive myopia, keratoconus or keratoconus suspect in either eye
3. Abnormal corneal topographic findings in either eye e.g., keratoconus, pellucid marginal degeneration
4. Treatment targeted for monovision
5. Signs and symptoms of dry eye based on: (a) Corneal fluorescein staining total score ≥4 in the National Eye Institute (NEI)/Industry Workshop scale in either eye, (b) Anethetized Schirmer test score ≤5 mm/5 minutes in either eye, (c) Symptom score ≤40 using the Symptom Assessment in Dry Eye (SANDE) questionnaire in either eye
6. Female subjects who are pregnant, breastfeeding or intend to become pregnant during the study. Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not.
7. Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as iritis, uveitis, keratoconjunctivitis sicca, herpetic keratitis, vernal conjunctivitis, lagophthalmos, corneal scarring, anterior basement membrane disease, recurrent erosions, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts
8. Previous corneal or intraocular surgery in either eye for refractive or therapeutic purposes
9. Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane®), amiodarone hydrochloride (Cordarone®) and/or sumatriptan (Imitrex®) (other medications in the same family as Imitrex will still be allowed)
10. Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
11. Individuals not legally competent to provide informed consent (e.g., incapacitated individuals, cognitively impaired) will not be enrolled. All subjects must provide consent to participate in the study

Study Design

Enrollment

88 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

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

Interventions

0.00025% Lacripep ophthalmic solution and Placebo

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

Primary outcome measure

  • Efficacy of Lacripep [ Time Frame: Epithelial thickness assessment will be performed at 4 and 7 days postoperatively then at 1, 3 and 6 months postoperatively. ]

Central Contacts and Locations

Locations

Alexander T. Augusta Military Medical Center

Recruiting

Fort Belvoir, Virginia, United States, 22060

Contacts

Principal Investigator:

Benjamin G Kuhar, OD

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Cornea
  • Wound healing
  • PRK
  • Lacritin
  • Lacripep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2026-09-03.