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New treatment option for Ocular Surface Disease
Official title Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
ClinicalTrials.gov ID: NCT07502378
What this study is testing
What is Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.?
Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. is an investigational medicine, being studied as a potential treatment for ocular surface disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Neurotrophic Keratopathy stage 1 diagnosis based on the following: Presence of 3+ fluorescein staining in central cornea and decreased corneal...
- 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).
You likely can't join if
- 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...
- History of any ocular surgery within three months before study visit 1.
See the full eligibility 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).
- 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 people 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
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.