Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07502378
Phase
PHASE4
Status
Recruiting

Conditions

  • Neurotrophic Keratopathy Stage 1
  • Ocular Surface Disease

Eligibility Criteria

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

Interventions

  • Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. — DRUG
    This is an FDA approved drug. The participants will be educated on the potential instillation site sensation that may occur as reported from the Pivotal Trials and that the sensation may differ between eyes due to the Neurotrophic Keratopathy. Qualified eyes must meet the inclusion and exclusion criteria. If both eyes qualify, then the one with the worst vision will be the study eye. If both eyes have equal visual acuity then the right eye will be the study eye.
  • Alternative would be patient exiting the trial and starting on tears or other standard of care. — OTHER
    This is an open label trial. If the patient does not do well on Acoltremon Ophthalmic Solution, then the participant will be removed from trial and put on standard of care treatment, other than Acoltremon.

Study Details

STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.

Key Dates

Start date
Mar 27, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Acoltremon 0.003% Ophthalmic Solution
    Open Label treatment of Acoltremon

Primary Outcome Measure

Unanesthetized Schirmer Test [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South Florida/OphthalmologyTampaFlorida33612
Angie Windham
813-974-1423
Susan Sherouse
813-974-0948
Pedram Hamrah, MD (PRINCIPAL_INVESTIGATOR)

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