Lacripep eye drops to speed corneal healing after PRK
Lacripep, a Novel Investigational Agent, for Corneal Wound Healing and Ocular Surface Homeostasis
This trial tests whether Lacripep eye drops help people who have PRK or similar superficial corneal injuries heal faster and regain vision sooner.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine Academic / other |
| Locations | 1 site (Fort Belvoir, Virginia) |
| Trial ID | NCT06854393 on ClinicalTrials.gov |
What this trial studies
This Phase 2, randomized interventional study compares 0.00025% Lacripep ophthalmic solution with a placebo eye drop in patients undergoing bilateral photorefractive keratectomy (PRK). Participants are active-duty U.S. service members or eligible dependents and will be followed for safety and healing outcomes for up to six months after surgery. The study measures corneal epithelial wound closure, visual recovery, and adverse events after topical administration of the study drug. Results will determine whether Lacripep can shorten healing time and improve early visual outcomes after superficial corneal injury or surgery.
Who should consider this trial
Good fit: Ideal candidates are active-duty service members or their dependents aged 21 or older who elect bilateral PRK for myopia up to -4.00 D with stable refraction, good corrected vision, and who can attend follow-up for six months.
Not a fit: Patients with planned ablation depths over 75 microns, signs of keratoconus or unstable/progressive myopia, or those not eligible for military care are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, Lacripep could shorten corneal epithelial healing time and speed visual recovery after PRK or similar superficial corneal injuries.
How similar studies have performed: Preclinical work and limited early human data on lacritin-derived therapies have shown promise for ocular surface healing, but controlled clinical evidence in post-PRK patients is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Fort Belvoir, Virginia
- Alexander T. Augusta Military Medical Center — Fort Belvoir, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Zachary P Skurski, DO — Alexander T. Augusta Military Medical Center
- Study coordinator: Zachary P Skurski, DO
- Email: Zachary.p.skurski.mil@health.mil
- Phone: 571-231-1670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.