Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
88 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-05-23
Study Completion Date
2027-09-30
Brief Summary
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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).
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Detailed Description
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The purpose of this study is to assess the effect of an eyedrop medication, Lacripep, on wound healing in the cornea (the transparent tissue covering the front of the eye) such as seen after incidental or combat related trauma, or from eye surgeries like Photorefractive keratectomy (PRK). This study will help understand if Lacripep is an effective treatment in ocular surface healing and speeding visual recovery after injury.
Participants must be an active-duty service member eligible for care at a military treatment facility.
Participants must be an active-duty service member eligible for care at a military treatment facility.
Conditions
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Corneal Epithelial Wound Healing
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Participants will:
1. Undergo photorefractive keratectomy (PKR), which is an eye surgery to improve vision.
2. Use two types of experimental eyedrops three times a day for three weeks. There will be separate containers of eyedrops for the right eye and the left eye. One eye will get the active eyedrop (Lacripep) and the other eye will get the placebo eyedrop (saline).
1. Undergo photorefractive keratectomy (PKR), which is an eye surgery to improve vision.
2. Use two types of experimental eyedrops three times a day for three weeks. There will be separate containers of eyedrops for the right eye and the left eye. One eye will get the active eyedrop (Lacripep) and the other eye will get the placebo eyedrop (saline).
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Participant will receive both active treatment and placebo at the same time. One eye will receive active treatment (Lacripep) and the other eye will receive placebo.
Study Groups
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Treatment
Participants will receive Lacripep in one eye and placebo in the other eye at the same time.
Group Type
EXPERIMENTAL
0.00025% Lacripep ophthalmic solution and Placebo
Intervention Type
DRUG
Participant will receive Lacripep in one eye and placebo in the other eye at the same time.
Interventions
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0.00025% Lacripep ophthalmic solution and Placebo
Participant will receive Lacripep in one eye and placebo in the other eye at the same time.
Intervention Type
DRUG
Eligibility Criteria
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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
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
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
Minimum Eligible Age
21 Years
Maximum Eligible Age
55 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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TearSolutions, Inc.
INDUSTRY
Sponsor Role
collaborator
Walter Reed National Military Medical Center
FED
Sponsor Role
collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Zachary P Skurski, DO
Role: PRINCIPAL_INVESTIGATOR
Alexander T. Augusta Military Medical Center
Locations
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Alexander T. Augusta Military Medical Center
Fort Belvoir, Virginia, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HT94252411092
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
WRNMMC-2024-0470
Identifier Type: -
Identifier Source: org_study_id
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