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

NCT06517667 | Completed Phase 2 DMC

• 1 other identifier: CIVIUS-ABS-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Lipid layer thickness (LLT)

  The Lipiview® (Johnson \& JohsonVision Care, San Francisco, CA, USA) II ocular surface interferometer evaluates LLT automatically assesses LLT with nanometer precision by recording a 20 s video of the tear film interference pattern and then displays the data in interferometric color units (ICU), where1 ICU reflects approximately 1 nm of LLT.

  This outcome measure was analyzed at baseline, 1 months and 3 months.

Secondary Outcomes (3)

• Ocular surface disease index questionnaire

  This outcome measure was analyzed at baseline, 1 months and 3 months.

• Non-invasive tear film break-up time

  This outcome measure was analyzed at baseline, 1 months and 3 months.

• Schirmer I test without anesthesia

  This outcome measure was analyzed at baseline, 1 months and 3 months.

Study Arms (2)

Cross-linked hyaluronic acid

EXPERIMENTAL

Tear substitute based on 0.20% Cross-linked hyaluronic acid

Drug: Icross tear substitute

Hyaluronic acid

ACTIVE COMPARATOR

Tear substitute based on 0.15% Cross-linked hyaluronic acid

Drug: Hyabak tear substitute

Interventions

Icross tear substitute 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.

Cross-linked hyaluronic acid

Hyabak tear substitute DRUG

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

Hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported history DED.
• Ocular surface disease index (OSDI) \> 13 points.
• Non-invasive tear film break-up time (NIBUT) \< 10 s.
• Schirmer test (ST) without anesthesia ≥ 5 mm.
• 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%).

You may not qualify if:

• Abnormal lid anatomy, including active blepharitis, and active lid margin.
• All corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies.
• Active ocular allergies.
• Vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecular resonance (QMR), or other procedure to treat DED within the previous 6 months.
• Intraocular surgery or laser ocular surgery within the previous 6 months.
• Use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs.
• Systemic autoimmune diseases.
• Contact lens wearers.
• Pregnant or lactating women.
• Patients who did not understand or comprehend the informed consent.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Novovision ophthalmologic clinic

Murcia, 30009, Spain

Location

Related Publications (4)

• Postorino EI, Rania L, Aragona E, Mannucci C, Alibrandi A, Calapai G, Puzzolo D, Aragona P. Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye. Eur J Ophthalmol. 2018 Jan;28(1):25-31. doi: 10.5301/ejo.5001011. Epub 2018 Feb 19.

  PMID: 28777385 RESULT

• Posarelli C, Passani A, Del Re M, Fogli S, Toro MD, Ferreras A, Figus M. Cross-Linked Hyaluronic Acid as Tear Film Substitute. J Ocul Pharmacol Ther. 2019 Sep;35(7):381-387. doi: 10.1089/jop.2018.0151. Epub 2019 Aug 2.

  PMID: 31373862 RESULT

• Ali S, Davinelli S, Mencucci R, Fusi F, Scuderi G, Costagliola C, Scapagnini G. Crosslinked Hyaluronic Acid with Liposomes and Crocin Confers Cytoprotection in an Experimental Model of Dry Eye. Molecules. 2021 Feb 6;26(4):849. doi: 10.3390/molecules26040849.

  PMID: 33561944 RESULT

• Guarise C, Acquasaliente L, Pasut G, Pavan M, Soato M, Garofolin G, Beninatto R, Giacomel E, Sartori E, Galesso D. The role of high molecular weight hyaluronic acid in mucoadhesion on an ocular surface model. J Mech Behav Biomed Mater. 2023 Jul;143:105908. doi: 10.1016/j.jmbbm.2023.105908. Epub 2023 May 15.

  PMID: 37209594 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• José-María Sánchez-González

  University of Seville

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: November 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

ES (1)