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

March 5, 2025 updated by: Rajavithi Hospital

Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient with Moderate to Severe Dry Eye : a Randomized Double-blind Controlled Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital, 2, Phayathai Road, Ratchathewi District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age more than or equal 18 year-old
  • Ocular Surface Disease Index (OSDI) more than or equal 23
  • Oxford grading scale more than or equal 2 (both eye)
  • Fluorescein tear break-up time less than 7 seconds (both eyes)
  • Willing to being a subject in research.

Exclusion Criteria:

  • Diagnosed with other eye diseases that require medication which is not used to treat dry eye, such as Glaucoma
  • History of Ocular surgery in previous 3 months or Refractive surgery in previous 6 months
  • History of ocular trauma, infection, ocular inflammation which is not involved with dry eye in previous 3 months
  • Wear contact lenses
  • Allergic to Sodium hyaluronate
  • Pregnant or lactation period
  • Diagnosed with physical diseases that affect the eyes and cannot yet be controlled, such as uncontrolled DM (Diabetes Mellitus), active autoimmune disease, and systemic neuropathy induced neurotrophic keratopathy. - Continuous use of medications for diseases such as Retinoic acid derivatives, Antihistamines, Cholinergic agents, and Antipsychotic agents which can lead to chronic dry eye
  • Incompleted data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vismax
0.28% Sodium Hyaluronate , preservative free eye drops
Drug: 0.28% Sodium Hyaluronate , preservative free eye drops
0.28% Sodium Hyaluronate , preservative free eye drops
Active Comparator: Vislube
0.18% Sodium Hyaluronate , preservative free eye drops
Drug: 0.18% Sodium Hyaluronate , preservative free eye drops
0.18% Sodium Hyaluronate , preservative free eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To examine the effect of 0.28% Sodium Hyaluronate on corneal epithelial healing
Time Frame: 30 days
The Oxford grading scale was used. This scale consists of six levels: 0, I, II, III, IV, and V, with higher values indicating more severe punctate epithelial erosion.
30 days
To examine the effect of 0.28% Sodium Hyaluronate on reducing tear osmolarity
Time Frame: 60 minutes
Tear osmolarity was monitored before and after the intervention in both arms. Abnormal Tear Osmolarity is defined as a value of ≥ 308 mOsmol/L, measured using the TearLab® system.
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3. To study the stability of the tear film following the administration of 0.28% Sodium Hyaluronate
Time Frame: 0 minutes, 60 minutes, and 30 days.
Fluorescein Tear Break-Up Time (FTBUT) was measured in seconds. Abnormal values are defined as a tear break-up time of ≥ 10 seconds.
0 minutes, 60 minutes, and 30 days.
To assess dry eye symptoms following the administration of 0.28% Sodium Hyaluronate
Time Frame: 0 minutes and 30 days.
The Ocular Surface Disease Index (OSDI) was used. The final score is calculated on a scale from 0 to 100, with higher scores indicating greater severity of ocular surface dysfunction.
0 minutes and 30 days.
To assess quality of life following the administration of 0.28% Sodium Hyaluronate
Time Frame: 0 minutes and 30 days.
The Dry Eye-Related Quality of Life Score (DEQS-Th) was used. The final score is calculated on a scale from 0 to 100, with higher scores indicating greater severity of ocular surface dysfunction.
0 minutes and 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Investigators

  • Principal Investigator: Pornlada Sunlakaviset, MD., Rajavithi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

May 26, 2025

Study Completion (Estimated)

June 26, 2025

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient data cannot be disclosed to other researchers because prior consent was not obtained from the patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe