NCT07281950

Investigator Initiated Trial Using Dry Eye Surveys to Evaluate and Better Understand FDA Approved Acoltremon Treatment for Dry Eye Disease in Real World Treatment Settings (DESERT)

Dry Eye Surveys to Evaluate Acoltremon in Real World Treatment (DESERT)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Center for Sight Las Vegas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Dry eye disease (DED) is a common, chronic and multifactorial disease of the ocular surface presenting with signs and symptoms of ocular discomfort, visual disturbance and fluctuation, tear film instability, ocular surface inflammation and damage. It significantly affects patients' quality of life and is one of the most frequent reasons for visits to eye care providers. Many patients remain symptomatic in real-world settings despite current pharmacologic therapeutic options available. As symptoms often lag behind ocular signs, a 3 month study with multiple time points has been designed to assess short term and mid-term symptomatic changes. This study will use Dry Eye Surveys to evaluate Acoltremon in Real World Settings to help understand its real world effectiveness and potential to improve symptoms in dry eye patients.

Detailed description

TRYPTYR (Acoltremon 0.003%) is a newly FDA approved therapy for dry eye disease with a novel mechanism of action. It is a TRPM8 receptor agonist that stimulates trigeminal nerve signaling, which has been associated with increased basal tear production. As randomized clinical trials are conducted under highly controlled conditions, their results may not fully represent the effectiveness of drugs in real-world settings. Given TRYPTYR's (Acoltremon 0.003%) recent approval, there is a need to better understand how the medication performs in real-world settings and generate real-world evidence to assess its effectiveness and impact on patient-reported symptoms in individuals with dry eye disease (DED). Real-world data is essential to evaluate treatment outcomes in routine clinical practice. The SPEED (Standard Patient Evaluation of Eye Dryness) questionnaire is a widely accepted clinical tool that captures the frequency and severity of DED symptoms from the patient's perspective. Incorporating the SPEED questionnaire into this study will enable a robust assessment of symptom burden and treatment-related changes, thereby addressing a critical unmet need in understanding TRYPTYR's real-world effectiveness and its potential to improve symptoms in DED patients.

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
DRUG	acoltremon 0.003%	single arm

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2025-12-15
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study