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Tests treatment safety and results for Neurotrophic Keratitis
Official title A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis
ClinicalTrials.gov ID: NCT07568730
What this study is testing
What is Lacripep?
Lacripep is an investigational medicine, being studied as a potential treatment for neurotrophic keratitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Objective: To evaluate the safety of Lacripep 4 μM Ophthalmic Solution and its effect on the ocular surface, visual function, corneal sensitivity, and quality of life of subjects with Stage 1 NK.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people who meet all the following at Visit 1 (Screening) will be eligible to participate in the study.
- Are ≥18 years of age.
- Provide informed consent before any study-related procedures are performed.
- Are willing and able to comply with study procedures and the study schedule.
- Female people must either be incapable of pregnancy or must use an effective method of birth control for the duration of the study. Female people of...
You likely can't join if
- people who meet any of the following exclusion criteria at Visit 1 (Screening) will not be eligible to participate in the study. Ocular criteria...
- Have received prior treatment with Lacripep Ophthalmic Solution or Oxervate® (cenegermin-bkbj) Ophthalmic Solution within 6 months prior to Visit 1...
- Have participated in a NK study within 90 days prior to Visit 1 (Screening).
- Have participated in any other clinical study or used an investigational agent within 30 days prior to Screening or plans to participate in another...
- Have a glycated hemoglobin (HbA1c) score \>9% within 90 days prior to Visit 1 (Screening).
- Have a history of or current conditions that may confound the study data; such conditions include but are not limited to ocular cicatricial...
See the full eligibility criteria
- people who meet all the following at Visit 1 (Screening) will be eligible to participate in the study.
- Are ≥18 years of age.
- Provide informed consent before any study-related procedures are performed.
- Are willing and able to comply with study procedures and the study schedule.
- Female people must either be incapable of pregnancy or must use an effective method of birth control for the duration of the study. Female people of childbearing potential must have a negative pregnancy test and not be...
- Have all of the following in at least one eye:
- Stage 1 NK as defined by:
- Grade 3 cCFS using the National Eye Institute (NEI) scale (0-3 in one-point increments).
- Corneal sensitivity ≤4 cm in the central zone, as measured by Cochet-Bonnet aesthesiometer.
- BCDVA +0.2 to +1.0 logarithm of the minimum angle of resolution (logMAR) (Snellen equivalent 20/32 to 20/200).
- IOP ≤21 mmHg.
- people who meet any of the following exclusion criteria at Visit 1 (Screening) will not be eligible to participate in the study. Ocular criteria apply to each eye independently, unless otherwise noted.
- Have received prior treatment with Lacripep Ophthalmic Solution or Oxervate® (cenegermin-bkbj) Ophthalmic Solution within 6 months prior to Visit 1 (Screening) and failed to demonstrate a clinically meaningful response...
- Have participated in a NK study within 90 days prior to Visit 1 (Screening).
- Have participated in any other clinical study or used an investigational agent within 30 days prior to Screening or plans to participate in another clinical study at any time during the conduct of this study.
- Have a glycated hemoglobin (HbA1c) score \>9% within 90 days prior to Visit 1 (Screening).
- Have a history of or current conditions that may confound the study data; such conditions include but are not limited to ocular cicatricial pemphigoid, graft versus host disease, neuromyelitis optica, Stevens-Johnson...
- Have an unstable history of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the study period) or chronic conjunctivitis and/or keratitis other than dry eye disease.
- Have been diagnosed with glaucoma or are a glaucoma suspect who requires or may require treatment during the study.
- Have, in the opinion of the Investigator, evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
- Have any intraocular inflammation (Tyndall score \>0).
- Have, in the opinion of the Investigator, severe vision loss due to retinal disease, with no potential for visual improvement.
- Have an eyelid abnormality that may alter eyelid function; such abnormalities include but are not limited to blepharospasm, cerebrovascular accident, entropion, ectropion, and floppy lid syndrome.
- Have punctal occlusion or punctal plugs that will not be maintained during the study period.
- Have had any corneal surface procedure within 90 days prior to Visit 1 (Screening). This includes laser-assisted in situ keratomileusis (LASIK), phototherapeutic or photorefractive keratectomy (PTK or PRK), radial...
- Have, in the opinion of the Investigator, NK that was induced by a neurosurgical procedure.
- Have undergone any other ocular surgery (including peripheral iridotomy (PI), laser iridotomy (LI) eyelid surgery and any surgical refractive procedures) within 90 days prior to Visit 1 (Screening) or expect to undergo...
- Have, in the opinion of the Investigator, history of viral corneal disease that resulted in significant corneal scarring.
- Have viral corneal disease without scarring that is considered unstable prior to Visit 1 (Screening), defined as discontinuation of topical ocular antiviral therapy or topical ocular steroid therapy within 2 weeks prior...
- Have received Botox (botulinum toxin) ocular injections to induce pharmacologic blepharoptosis within 45 days prior to Visit 1 (Screening).
- Have used any non-study issued eye drops or neurostimulators within 14 days prior to Visit 2 (Day 1; Baseline/Randomization).
- Anticipate a need to use therapeutic contact lenses or unwilling to discontinue wearing contact lenses for refractive correction during the study period.
- Have, in the opinion of the Investigator, an unstable medical condition that may confound the study data; such conditions include but are not limited to diabetes, thyroid disease, autoimmune disease, Parkinson's...
- Evidence of current drug or alcohol abuse or addiction, in the opinion of the Investigator.
- Are pregnant, nursing, or planning a pregnancy during the study period.
- Are an employee of a site directly involved in the management, administration, or support of the study or an immediate family member of the same.
The study team makes the final eligibility decision.
Where it's taking place
- Carmel, Indiana, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Carmel, Indiana, United States; Minneapolis, Minnesota, United States; St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.