Dry Eye Surveys to Evaluate Acoltremon in Real World Treatment (DESERT)
Center for Sight Las Vegas
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Male or female adults age 18 and older at Visit 1 * Have a previous history of dry eye disease, clinician diagnosed or self-reported, for at least 3 months * Total SPEED score ≥ 6 on SPEED questionnaire at Visit 1 Screening \& Baseline Exclusion Criteria: * History of ocular surgery (excluding LASIK or PRK) in the past 3 months * History of LASIK or PRK in the past 12 months * Initiation, discontinuation or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) less than 14 days prior to Visit 1 or a cha…
Interventions
- Drugacoltremon 0.003%
single arm
Location
- Center for SightLas Vegas, Nevada