ArticleOphthalmology and therapy2026
A Randomized Multicenter Study Comparing Low-Viscosity with Comparator 0.3% Hyaluronic Acid for the Treatment of Dry Eye Disease.
Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06388070 (A Multicenter, Randomized, Double-blinded, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared With Hyalein Mini Eye Drops in Patients With Dry Eye Syndrome), which is not on this map. Not yet cited in PubMed.
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A Multicenter, Randomized, Double-blinded, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared With Hyalein Mini Eye Drops in Patients With Dry Eye Syndrome
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Abstract
introductionTo compare the efficacy and safety of a low-viscosity 0.3% hyaluronic acid (HA) ophthalmic solution with those of a comparator 0.3% HA formulation in patients with dry eye disease (DED).
methodsIn this double-blind, randomized, multicenter, noninferiority clinical trial, patients with mild-to-moderate DED were allocated at a 1:1 ratio to receive either low-viscosity or comparator 0.3% HA eye drops. Participants instilled the assigned study medications 5-6 times daily for 12 weeks, and a follow-up evaluation was conducted 1 week after the final instillation. The primary end point was the mean change in the corneal fluorescein staining (CFS) score from baseline to week 12. Secondary outcomes included the conjunctival staining score, tear break-up time (TBUT), nonanesthetized Schirmer test results, ocular surface disease index (OSDI) score, and ocular soreness.
resultsA total of 292 participants were included in the full analysis set. The change in CFS score at week 12 (-0.03; 95% CI -0.1873 to 0.1346) met the predefined noninferiority margin. Compared with the baseline parameters, both formulations significantly improved all ocular surface parameters except ocular soreness score (all P < 0.01). No significant between-group differences were observed across all secondary outcomes. Notably, blurred vision immediately after instillation was significantly less frequent in the low-viscosity HA group at all time points (P < 0.01).
conclusionsCompared with the comparator 0.3% HA formulation, the low-viscosity 0.3% HA formulation demonstrated comparable therapeutic benefits while reducing the incidence of viscosity-related adverse events. These findings indicated that the low-viscosity 0.3% HA ophthalmic solution may serve as a clinically meaningful alternative for patients with mild-to-moderate DED.
trial registrationClinicalTrials.gov identifier NCT06388070.
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