Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the study is to compare the efficacy and safety of different hyaluronic acid tear substitutes formulations in patients with evaporative dry eye. For this purpose, a randomized, single-blind clinical trial has been designed.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Tear Substitute Use on Dry Eye in Gamers.

NCT05536661

Evaporative Dry Eye

COMPLETED NA

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

NCT06478134

Dry Eye

COMPLETED PHASE2/PHASE3

Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye

NCT03617315

Dry Eye Meibomian Gland Dysfunction Dry Eye Syndromes

COMPLETED NA

To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome

NCT06388070

Dry Eye Syndromes

COMPLETED PHASE3

A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye

NCT04092907

Dry Eye

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were instructed to instill 1 drop of 0.20% Cross-linked hyaluronic acid tear substitute or 0.15% hyaluronic acid A tear substitute into each eye 3 times per day for 3 months.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

0.20% Cross-linked hyaluronic acid tear substitute and 0.15% hyaluronic acid 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

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cross-linked hyaluronic acid

Tear substitute based on 0.20% Cross-linked hyaluronic acid

Group Type EXPERIMENTAL

Icross tear substitute

Intervention Type DRUG

Patients were instructed to instill 1 drop of 0.20% Cross-linked hyaluronic acid substitute into each eye 3 times per day for 3 months.

Hyaluronic acid

Tear substitute based on 0.15% Cross-linked hyaluronic acid

Group Type ACTIVE_COMPARATOR

Hyabak tear substitute

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Icross tear substitute

Patients were instructed to instill 1 drop of 0.20% Cross-linked hyaluronic acid substitute into each eye 3 times per day for 3 months.

Intervention Type DRUG

Hyabak tear substitute

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Self-reported history DED.
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