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NCT06860659 · ClinicalTrials.gov record · last posted 2025-03-06

Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye

StatusEnrolling by Invitation
PhasePhase 4
Started2024-09-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 6, 2025 (before its estimated May 26, 2025 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
This study aimed to evaluate the efficacy and safety of 0.28% preservative-free SH and 0.18% SH eye drops in patients with dry eye disease. Subjects diagnosed with dry eye disease and meeting the inclusion criteria (Ocular Surface Disease Index (OSDI) score ≥ 23, Fluorescein Tear Breakup Time (TBUT) \< 7 seconds were randomized into two groups. Group 1 (42 eyes) received 0.28% SH, and Group 2 (42 eyes) received 0.18% SH, both administered by a nurse. Measurements included tear osmolarity (TearLAB) before instillation and at 0,30 and 60 minutes post-instillation, recorded by a TearLAB specialist. Ophthalmologists assessed TBUT, ocular surface staining (Oxford grading scale), and the Schirmer I test before instillation and evaluated adverse reactions up to 60 minutes post-instillation. Subjects continued treatment for 30 days and were reevaluated during a second visit for OSDI scores, TBUT, the Oxford grading scale, and adverse events. Quality of life score were assessed at before and after treatment for 1 month.
Trial Details
NCT Number NCT06860659
Lead Sponsor Department of Medical Services Ministry of Public Health of Thailand
Conditions Dry Eye Disease (DED), Tear Break-Up Time, Tear Disorder, Tear Film Insufficiency, Tear Film Hyperosmolarity, Dry Eye, Hyaluronate, Hyaluronic Acid +2 more
Enrollment 84 participants
Start Date 2024-09-01
Primary Completion 2025-05-26 (estimated)
Study Completion 2025-06-26 (estimated)
Updated on ClinicalTrials.gov 2025-03-06