NCT06262100

Lubricating Effectiveness of Carragelose Eye Drops in Patients Affected by Mild to Moderate Dry Eye

Clinical Investigation to Evaluate the Lubricating Performance of Carragelose Containing Eye Drops in Patients Diagnosed with Mild-to-moderate Dry Eye Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Marinomed Biotech AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients suffering from dry eye syndrom will treat their eyes with Carragelose® eye drops three times a day for 28 days. Before, in the middle and at the end of the treament period patients will be exposed to adverse conditions to challenge dry eye symptoms. Patient will record their occular symptoms and ophthalmic examinations will be performed by an ophthalmologist. Differences between before and after treatment will be assessed.

Detailed description

The objective is to evaluate the safety and performance of Carragelose®-containing eye drops in treating symptoms and signs of dry eye syndrom. Patients will treat their eyes with one eye drop three times a day for 28 days. Baseline assessment will be performed after normal controlled environment and after adverse controlled environment. At the end of investigation ocular symptoms and ocular sign will be assessed after normal controlled environment and after adverse controlled environment. Differences between baseline and end of investigation will be evaluated for efficacy analysis.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	Carragelose	Application of Carragelose containing eye drops

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2024-02-15
• Last updated: 2024-12-09

Locations

1 site across 1 country: Spain