Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- University of South Florida
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Unanesthetized Schirmer Test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Arms & Interventions
Acoltremon 0.003% Ophthalmic Solution
Open Label treatment of Acoltremon
Intervention: Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. (Drug)
Acoltremon 0.003% Ophthalmic Solution
Open Label treatment of Acoltremon
Intervention: Alternative would be patient exiting the trial and starting on tears or other standard of care. (Other)
Outcomes
Primary Outcomes
Unanesthetized Schirmer Test
Time Frame: 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 Outcomes
- Unanesthetized Schirmer test(1 Day)