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NCT Number: NCT06860659

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

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.

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Key information

Conditions

Dry Eye Disease (DED) Conjunctival Diseases Corneal Staining Dry Eye Dry Eye Syndromes Eye Diseases Hyaluronate Hyaluronic Acid Lacrimal Apparatus Diseases Quality of Life Tear Break-Up Time Tear Disorder Tear Film Hyperosmolarity Tear Film Insufficiency Xerophthalmia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rajavithi Hospital, 2, Phayathai Road, Ratchathewi District

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.28% Sodium Hyaluronate , preservative free eye drops

Drug

0.28% Sodium Hyaluronate , preservative free eye drops

0.18% Sodium Hyaluronate , preservative free eye drops

Drug

0.18% Sodium Hyaluronate , preservative free eye drops

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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