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

June 21, 2024 updated by: José-María Sánchez-González, University of Seville

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30009
        • Novovision ophthalmologic clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Self-reported history DED while working with computer screens ≥ 6 hours per day.
  2. ocular surface disease index (OSDI) > 13 points.
  3. non-invasive tear film break-up time (NIBUT) < 10 s.
  4. Schirmer test (ST) without anesthesia ≥ 5 mm.
  5. MGD grade ≤ 1. For MGD, the Sirius device (CSO, Florence, Italy) was used, which determines MGD grade based on loss area of meibomian glands (LAMG). MGD grade was scored from 0 to 4 (MGD grade 1 = LAMG < 25%; MGD grade 2 = LAMG ≥ 25% and < 50%; MGD grade 3 = LAMG ≥ 50% and < 75%; MGD grade 4 = LAMG ≥ 75%).

Exclusion Criteria:

  1. abnormal lid anatomy, including active blepharitis, and active lid margin.
  2. all corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies.
  3. active ocular allergies.
  4. vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecular resonance (QMR), or other procedure to treat DED within the previous 6 months.
  5. intraocular surgery or laser ocular surgery within the previous 6 months.
  6. use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs.
  7. systemic autoimmune diseases.
  8. contact lens wearers.
  9. pregnant or lactating women.
  10. patients who did not understand or comprehend the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TriMix
A new-generation tear substitute containing cross-linked hyaluronic acid 0.15%, trehalose 3%, liposomes 1% and sterylamine 0.25%.
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.
Active Comparator: Hyaluronic acid
0.15% Hyaluronic acid tear substitute.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular surface disease index questionnaire
Time Frame: This outcome measure was analyzed at baseline, 3 months and 6 months.
The OSDI questionnaire were employed to assess the severity of DED symptoms, with scores ranging from 0 (indicating no ocular surface disease) to 100 (indicating severe ocular surface disease) points. This questionnaire was provided during consultations at each follow-up visit.
This outcome measure was analyzed at baseline, 3 months and 6 months.
Non-invasive tear film break-up time
Time Frame: This outcome measure was analyzed at baseline, 3 months and 6 months.
Tear film stability was automatically assessed using NIBUT by projecting Placido rings from the Sirius device (CSO, Florence, Italy) onto the corneal surface. The time interval between the last blink and the initial distortion of the ring pattern was defined as first NIBUT. This variable was always measured at least 12 hours after administration of the study medication and the average of 3 consecutive measurements was calculated for statistical analysis.
This outcome measure was analyzed at baseline, 3 months and 6 months.
Schirmer I test without anesthesia
Time Frame: This outcome measure was analyzed at baseline, 3 months and 6 months.
During the test, the patient is instructed to look upward while the test strip is carefully positioned between the palpebral conjunctiva of the lower eyelid and the bulbar conjunctiva. Subsequently, the patient is asked to keep their eyes gently closed for five minutes. After this period, the test strip is removed, and the Schirmer test score is determined by measuring the length of the moistened area on the strip.
This outcome measure was analyzed at baseline, 3 months and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Investigators

  • Study Director: José-María Sánchez-González, University of Seville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

January 10, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIVIUS-ABS-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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