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

Phase 4

• Conditions: Dry Eye Disease (DED); Tear Break-Up Time; Tear Disorder; Tear Film Insufficiency; Tear Film Hyperosmolarity; Corneal Staining; Dry Eye; Hyaluronate; Hyaluronic Acid; Quality of Life
• Interventions: Drug: 0.28% Sodium Hyaluronate , preservative free eye drops; Drug: 0.18% Sodium Hyaluronate , preservative free eye drops

• Registration Number: NCT06860659
• Lead Sponsor: Rajavithi Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2025-02-18
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-05-26
• Study Completion: 2025-06-26

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vismax	0.28% Sodium Hyaluronate , preservative free eye drops	0.28% Sodium Hyaluronate , preservative free eye drops
Vislube	0.18% Sodium Hyaluronate , preservative free eye drops	0.18% Sodium Hyaluronate , preservative free eye drops

Primary Outcome Measures

Name	Time	Method
To examine the effect of 0.28% Sodium Hyaluronate on corneal epithelial healing	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.
To examine the effect of 0.28% Sodium Hyaluronate on reducing tear osmolarity	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 Outcome Measures

Name	Time	Method
3. To study the stability of the tear film following the administration of 0.28% Sodium Hyaluronate	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.
To assess dry eye symptoms following the administration of 0.28% Sodium Hyaluronate	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.
To assess quality of life following the administration of 0.28% Sodium Hyaluronate	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.

Trial Locations

Locations (1)

Rajavithi Hospital, 2, Phayathai Road, Ratchathewi District; 🇹🇭 Bangkok, Thailand