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

Phase 4Enrolling By InvitationNCT06860659

Department of Medical Services Ministry of Public Health of Thailand84 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Disease (DED)Tear Break-Up Time Tear Disorder

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To examine the effect of 0.28% Sodium Hyaluronate on corneal epithelial healing

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.

Time frame: 30 days

To examine the effect of 0.28% Sodium Hyaluronate on reducing tear osmolarity

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.

Time frame: 60 minutes

Secondary Outcomes

3. To study the stability of the tear film following the administration of 0.28% Sodium Hyaluronate

Fluorescein Tear Break-Up Time (FTBUT) was measured in seconds. Abnormal values are defined as a tear break-up time of ≥ 10 seconds.

Time frame: 0 minutes, 60 minutes, and 30 days.

To assess dry eye symptoms following the administration of 0.28% Sodium Hyaluronate

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.

Time frame: 0 minutes and 30 days.

To assess quality of life following the administration of 0.28% Sodium Hyaluronate

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.