Neurotrophic Keratopathy Stage 1, Ocular Surface Disease
Conditions
Keywords
Ocular Surface Disease
Brief summary
STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
Detailed description
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.
Interventions
DRUGPatients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.
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.
OTHERAlternative would be patient exiting the trial and starting on tears or other standard of care.
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.
Sponsors
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single arm trial where all patients receive the same medication in one eye. This study drug is already FDA approved and this is to get further detail of performance of the medication.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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. * Inability to suspend topical medications 8 days prior to the starting date and artificial tears 2 hours prior to the first study visit and remain off for the duration of the study. * History of any ocular surgery within three months before study visit 1. * Ocular surgery expected during the duration of the study. * Use of refractive/therapeutic contact lenses during the study period. * Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period. * Drug addiction/alcohol abuse. * Participation in another clinical trial concurrently
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unanesthetized Schirmer Test | 8 weeks | Mean change in unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unanesthetized Schirmer test | 1 Day | Mean change in unanesthetized Schirmer test score between 3 mins post-drop day 1 compared to pre-drop at day 1. |
Countries
United States
Contacts
CONTACTPedram Hamrah, MD
CONTACTSusan Sherouse
PRINCIPAL_INVESTIGATORPedram Hamrah, MD
University of South Florida
Outcome results
None listed