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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were instructed to instill 1 drop TriMix tear substitute or 0.15% HA tear substitute into each eye 3 times per day for 6 months. HA-based tear substitutes can reduce tear film hyperosmolarity and are effective in treating DED. Therefore, 0.15% HA tear substitute was selected as a suitable comparator.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

TriMix tear substitute and 0.15% HA tear substitute are transparent, with no special smell and the bottles were identical in appearance such that patients, investigators and care provider were masked to treatment assignment.

Study Groups

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TriMix

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

Group Type EXPERIMENTAL

Trimix tear substitutes

Intervention Type DRUG

Patients were instructed to instill 1 drop of TriMix tear substitute into each eye 3 times per day for 6 months.

Hyaluronic acid

0.15% Hyaluronic acid tear substitute.

Group Type ACTIVE_COMPARATOR

Hyaluronic acid tear substitute

Intervention Type DRUG

Patients were instructed to instill 1 drop of 0.15% HA tear substitute into each eye 3 times per day for 6 months.

Interventions

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Trimix tear substitutes

Patients were instructed to instill 1 drop of TriMix tear substitute into each eye 3 times per day for 6 months.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No