STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production in subjects with stage I neurotrophic keratopathy (NK). The study drug, Acoltremon, is formulated to help increase tear production. Since the tissue breakdown of the cornea is causing NK, it is thought that this study treatment may help participants with this disease by enhancing wound healing, repair and regeneration through improving nerve function of the cornea. Participants will be followed for 8 weeks, evaluating unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1), their mean change in Best Corrected distance visual acuity (ETDRS standards) from day 1 to week 8, and change in central corneal staining from baseline to week 8.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
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.
University of South Florida/Ophthalmology
Tampa, Florida, United States
RECRUITINGUnanesthetized Schirmer Test
Mean change in unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1)
Time frame: 8 weeks
Unanesthetized Schirmer test
Mean change in unanesthetized Schirmer test score between 3 mins post-drop day 1 compared to pre-drop at day 1.
Time frame: 1 Day
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