Efficacy of 0.28 % Sodium hyaluronate eye drops in patient with moderate to severe dry eye: A randomized double-blind controlled trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250211004

Enrollment

Registered

2025-02-11

Start date

2024-09-02

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye Tear osmolarity dry eye, moderate to severe dry eye, artificial tears, sodium hyaluronate eye drops, tear osmolarity, Oxford grading scale

Interventions

Non preservative 0.28% Sodium hyaluronate Eye drops ,Non preservative 0.18% Sodium hyaluronate Eye drops

Experimental Drug,Active Comparator Drug

Vismax,Vislube

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age more than or equal 18 year-old 2. Ocular Surface Disease Index (OSDI) more than or equal 23 3. Oxford grading scale more than or equal 2 (both eye) 4. Fluorescein tear break-up time less than 7 seconds (both eyes) - Willing to being a subject in research

Exclusion criteria

Exclusion criteria: 1. Diagnosed with other eye diseases that require medication which is not used to treat dry eye, such as Glaucoma. 2. History of Ocular surgery in previous 3 months or Refractive surgery in previous 6 months 3. History of ocular trauma, infection, ocular inflammation which is not involved with dry eye in previous 3 months 4. Wear contact lenses 5. Allergic to Sodium hyaluronate 6. Pregnant or lactation period 7. 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. 8. Continuous use of medications for diseases such as Retinoic acid derivatives, Antihistamines, Cholinergic agents, and Antipsychotic agents which can lead to chronic dry eye 10. Incompleted data

Design outcomes

Primary

Measure	Time frame
Efficacy between 0.28 % Sodium hyaluronate eye drops and 0.18 % Sodium hyaluronate eye drops 30 minutes, 60 minutes, 30 days Tear osmolarity, ocular surface staining, fluorescein tear break-up time, ocular surface index score	—

Secondary

Measure	Time frame
Side effect and safety of 0.28 % Sodium hyaluronate eye drops 1 year Data recorded	—

Countries

Thailand

Contacts

Public ContactPornlada Sunlakaviset

Rajavithi Hospital

pornladajoe@gmail.com0814996050

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026