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

University of Seville

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dry Eye

Treatments: Drug: Hyaluronic acid tear substitute; Drug: Trimix tear substitutes

Study type: Interventional

Funder types: Other

Identifiers

NCT06478134

CIVIUS-ABS-002

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups

TriMix

Experimental group

Description:

A new-generation tear substitute containing cross-linked hyaluronic acid 0.15%, trehalose 3%, liposomes 1% and sterylamine 0.25%.

Treatment:

Drug: Trimix tear substitutes

Hyaluronic acid

Active Comparator group

Description:

0.15% Hyaluronic acid tear substitute.

Treatment:

Drug: Hyaluronic acid tear substitute