STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
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).
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.
Single group
Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.
DrugThis 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 interventionThis 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.
Unanesthetized Schirmer Test
Mean change in unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1)
Unanesthetized Schirmer test
Mean change in unanesthetized Schirmer test score between 3 mins post-drop day 1 compared to pre-drop at day 1.
Corneal Staining
Change from baseline central corneal staining (NEI) at week 8.
Best Corrected Distance Visual Acuity
Change from baseline mean BCDVA (ETDRS) at week 8
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