๐ฌIn plain words
What the trial is, and whether it could suit you
STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โค 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
๐
What it tests
- Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.
- Alternative would be patient exiting the trial and starting on tears or other standard of care.
University of South Florida/Ophthalmology
Tampa, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.