Acoltremon for Dry Eye

Overseen By Susan Sherouse

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of South Florida

Must not be taking: Topical medications

Disqualifiers: Ocular infection, Corneal scar, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.

Who Is on the Research Team?

Pedram Hamrah, MD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

Inclusion Criteria

Baseline unanesthetized Schirmer's test ≤ 10 mm

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)

I have early-stage neurotrophic keratopathy with decreased corneal sensation.

Exclusion Criteria

I do not have any active eye infections or inflammation inside my eye.

I have a lasting corneal ulcer, scar, or swelling in my eye.

History of severe systemic allergies or severe ocular allergies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Acoltremon 0.003% Ophthalmic Solution to improve tear production and corneal health

8 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acoltremon Ophthalmic Solution 0.003%

How Is the Trial Designed?

Group I: Acoltremon 0.003% Ophthalmic Solution Experimental Treatment 2 Interventions

Open Label treatment of Acoltremon

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+