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

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.

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.