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

Last updated: July 24, 2024
Sponsor: University of Seville
Overall Status: Completed

Phase

2/3

Condition

Dry Eye Disease

Sjogren's Syndrome

Eyelid Inflammation

Treatment

Hyabak tear substitute

Icross tear substitute

Clinical Study ID

NCT06517667
CIVIUS-ABS-003
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, whichdetermines MGD grade based on loss area of meibomian glands (LAMG). MGD grade wasscored 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

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 infectionand corneal dystrophies.

  3. Active ocular allergies.

  4. Vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecularresonance (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 andnon-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 Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Hyabak tear substitute
Phase: 2/3
Study Start date:
November 01, 2023
Estimated Completion Date:
June 01, 2024

Connect with a study center

  • Novovision ophthalmologic clinic

    Murcia, 30009
    Spain

    Site Not Available

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