Clinical trial NCT06517667: Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye
Official title: Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye: A Randomized, Single-Blind, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lipid layer thickness (LLT)
timeFrame: This outcome measure was analyzed at baseline, 1 months and 3 months.
Secondary outcomes:
measure: Ocular surface disease index questionnaire
timeFrame: This outcome measure was analyzed at baseline, 1 months and 3 months.
measure: Non-invasive tear film break-up time
timeFrame: This outcome measure was analyzed at baseline, 1 months and 3 months.
measure: Schirmer I test without anesthesia
timeFrame: This outcome measure was analyzed at baseline, 1 months and 3 months.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Novovision ophthalmologic clinic
Study officials:
affiliation: University of Seville
name: José-María Sánchez-González
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.