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

NCT06860659 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-03-06

No results posted yet for this study

Summary

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.

Conditions

  • Dry Eye Disease (DED)
  • Tear Break-Up Time
  • Tear Disorder
  • Tear Film Insufficiency
  • Tear Film Hyperosmolarity
  • Dry Eye
  • Hyaluronate
  • Hyaluronic Acid
  • Corneal Staining
  • Quality of Life

Interventions

DRUG

0.28% Sodium Hyaluronate , preservative free eye drops

0.28% Sodium Hyaluronate , preservative free eye drops

DRUG

0.18% Sodium Hyaluronate , preservative free eye drops

0.18% Sodium Hyaluronate , preservative free eye drops

Sponsors & Collaborators

  • Department of Medical Services Ministry of Public Health of Thailand

    lead OTHER_GOV

Principal Investigators

  • Pornlada Sunlakaviset, MD. · Department of Medical Services Ministry of Public Health of Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-05-26
Completion
2025-06-26

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06860659 on ClinicalTrials.gov