A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis

Part of paid clinical trials in Carmel, Indiana.

Sponsor
TearSolutions, Inc.
Study ID
NCT07568730
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Neurotrophic Keratitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lacripep — DRUG
    Lacripep 4 μM Ophthalmic Solution
  • Vehicle Ophthalmic Solution — OTHER
    Vehicle ophthalmic solution

Study Details

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.

Key Dates

Start date
Feb 19, 2026
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lacripep
  • Placebo Comparator: Vehicle

Primary Outcome Measure

Primary Efficacy [ Time Frame: Baseline to Week 8 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Midwest Cornea AssociatesCarmelIndiana46032
Study Coordinator
[email protected]
317-817-1765
Minnesota Eye ConsultantsMinneapolisMinnesota55431
Study Coordinator
[email protected]
952.567.6111
Ophthalmology AssociatesSt LouisMissouri63131
Study Coordinator
[email protected]
314-966-3377

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By research site
Midwest Cornea Associates· Carmel, INMinnesota Eye Consultants· Minneapolis, MNOphthalmology Associates· St Louis, MO

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