Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease i… (NCT07502378) | Clinical Trial Compass
RecruitingPhase 4
Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
United States50 participantsStarted 2026-03-27
Plain-language summary
STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
Who can participate
Age range18 Years
SexALL
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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