NCT07268599

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

Acoltremon Symptom Tracking and Relief Assessment in Moderate-to-Severe Dry Eye Disease

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Colvard Kandavel Eye Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: —

Summary

To evaluate the impact of Acoltremon 0.003% on subjective dry eye symptoms using validated patient-reported outcome measures: Eye Dryness Score Visual Analog Scale (EDS-VAS). The primary aim is to characterize the rapidity of symptomatic relief in moderate to severe dry eye disease (DED), with attention to short-term therapy.

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
DRUG	Acoltremon	Patients will administer Acoltremon 0.003% as per labeled directions. Assessments with the Ocular Surface Disease Index (OSDI) will occur at Baseline, treatment at 14 days, and treatment at 28 days. Secondary endpoints include change from baseline rating scale 1-5 in severity of various symptoms of dry eye: Blurriness, eye irritation/Discomfort, Burning/Stinging, Photophobia/Pain, Sandy/gritty/Foreign Body Sensation, Fatigue/Tired Eyes).

Timeline

• Start date: 2025-11-24
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study