Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry… (NCT06517667) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye
Spain30 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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%).
Exclusion criteria
✕. 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.
What they're measuring
1
Lipid layer thickness (LLT)
Timeframe: This outcome measure was analyzed at baseline, 1 months and 3 months.