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

University of Seville

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dry Eye

Treatments: Drug: Icross tear substitute; Drug: Hyabak tear substitute

Study type: Interventional

Funder types: Other

Identifiers

NCT06517667

CIVIUS-ABS-003

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Cross-linked hyaluronic acid

Experimental group

Description:

Tear substitute based on 0.20% Cross-linked hyaluronic acid

Treatment:

Drug: Icross tear substitute

Hyaluronic acid

Active Comparator group

Description:

Tear substitute based on 0.15% Cross-linked hyaluronic acid

Treatment:

Drug: Hyabak tear substitute