Clinical trial NCT06860659: Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient with Moderate to Severe Dry Eye
Official title: Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient with Moderate to Severe Dry Eye : a Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
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
Keywords: tear osmolarity
artificial tears
oxford grading scale
DEQS-TH
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2025-03-06
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To examine the effect of 0.28% Sodium Hyaluronate on corneal epithelial healing
timeFrame: 30 days
measure: To examine the effect of 0.28% Sodium Hyaluronate on reducing tear osmolarity
timeFrame: 60 minutes
Secondary outcomes:
measure: 3. To study the stability of the tear film following the administration of 0.28% Sodium Hyaluronate
timeFrame: 0 minutes, 60 minutes, and 30 days.
measure: To assess dry eye symptoms following the administration of 0.28% Sodium Hyaluronate
timeFrame: 0 minutes and 30 days.
measure: To assess quality of life following the administration of 0.28% Sodium Hyaluronate
timeFrame: 0 minutes and 30 days.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital, 2, Phayathai Road, Ratchathewi District
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Pornlada Sunlakaviset, MD.
role: PRINCIPAL_INVESTIGATOR
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