NCT06478134

Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease

Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease: A Randomized, Double-blinded, HA-controlled Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to assess the efficacy and safety of TriMix tear substitute in patients with dry eye disease. For this purpose, a randomized, double-blind clinical trial has been designed, using an Hyaluronic acid-based tear substitute as a control.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Trimix tear substitutes	Patients were instructed to instill 1 drop of TriMix tear substitute into each eye 3 times per day for 6 months.
DRUG	Hyaluronic acid tear substitute	Patients were instructed to instill 1 drop of 0.15% HA tear substitute into each eye 3 times per day for 6 months.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-01-10
• Completion: 2024-05-01
• First posted: 2024-06-27
• Last updated: 2024-06-27

Locations

1 site across 1 country: Spain