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

Launched by DEPARTMENT OF MEDICAL SERVICES MINISTRY OF PUBLIC HEALTH OF THAILAND · Mar 5, 2025

Keywords

ClinConnect Summary

This study is a randomized, double-blind trial (neither participants nor doctors know which eye drop is being given) that tests two preservative-free sodium hyaluronate eye drops for dry eye disease. Adults 18 and older with moderate to severe symptoms are invited to participate. To be eligible, you would need an OSDI score of 23 or higher, signs of eye surface damage (Oxford grading scale in both eyes of 2 or more), and tear film instability (short TBUT less than 7 seconds in both eyes). People with other eye diseases needing treatment, recent eye surgery, contact lens wear, pregnancy, or certain other health issues would not be eligible. About 84 participants are planned, and the trial is in Bangkok, Thailand, at Rajavithi Hospital, funded by Thailand’s Department of Medical Services.

Participants will use one of two preservative-free eye drops for 30 days: 0.28% sodium hyaluronate (Vismax) or 0.18% sodium hyaluronate (Vislube). The nurse assigns and prepares the drops, while you and the doctors remain blinded to which drop you receive. The study measures tear saltiness (tear osmolarity) before and after instillation and again at 60 minutes, plus tests of tear film stability, corneal staining, tear production, symptoms, and quality of life at baseline and after about a month. Primary goals are to see if the 0.28% drops improve corneal healing after 30 days and affect tear osmolarity within 60 minutes. Secondary goals include tear film stability, symptom scores, and overall quality of life. The study started enrolling in 2024 and is expected to complete in mid-2025. No expanded access, and the sponsor is the Department of Medical Services, Ministry of Public Health of Thailand.

Gender

ALL

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.