Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT07281950
Brief 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.
Study:
NCT07281950
Study Brief:
Protocol Section:
NCT07281950