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

NCT06478134 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-06-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Seville

    lead OTHER

Principal Investigators

  • José-María Sánchez-González · University of Seville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-01-10
Completion
2024-05-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06478134 on ClinicalTrials.gov