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

ConditionsOcular Surface Disease Neurotrophic Keratopathy Stage 1

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of South Florida

About this trial

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

Eligibility criteria

Qualifiers

Neurotrophic Keratopathy stage 1 diagnosis based on the following: Presence of 3+ fluorescein staining in central cornea and decreased corneal sensation (Cochet-Bonnet less than 4cm in the central cornea)

Baseline unanesthetized Schirmer's test ≤ 10 mm

Females of childbearing potential must have a negative pregnancy test.

Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen <20/200).

Disqualifiers

Evidence of any active ocular infection or any intraocular inflammation.

Evidence of any persistent epithelial defect/ulcer or any corneal scar/corneal edema.

Presence of any other ocular conditions that require topical medications during the treatment phase.

History of severe systemic allergies or severe ocular allergies.

Trial design

Treatments tested in this trial

Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.
Alternative would be patient exiting the trial and starting on tears or other standard of care.

Treatment groups

50 Participants

are divided into 1 treatment group

Sponsors and collaborators

University of South Florida

Lead sponsor

Source ClinicalTrials.gov