Efficacy and safety of 0.28% Sodium Hyaluronate Eye Drops in Patients with Dry Eye Disease: A Randommized Controlled Pilot Study

Efficacy and Safety of 0.28% Sodiun Hyaluronate Eye Drops in Patients with Dry Eye Disease: A Randomized Controlled Pilot Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210219002

Enrollment

Registered

2021-02-19

Start date

2020-09-29

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 disease Efficacy Artificial tears sodium hyaluronate eye drops Tear osmolarity Ocular sarface staining OSDI Hyaluronic acid hyaluron

Interventions

New HA products,Original products

Experimental Drug,Experimental Drug

0.28% Sodium Hyaluronate eye drops,0.18% Sodium Hyaluronate eye drops

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age more than 18 years. Ocular surface disease Index not more than 13 Noninvasive tear break up time less than 10 seconds, both eyes. Schirmer 1 test more than 10 mm. (in 5 minutes), both eyes.

Exclusion criteria

Exclusion criteria: Oxford grading scale not more than 4 Previous preservative eye drop use in 1 week. Previous ocular surgery in 4 months. History of nasolacrimal duct obstruction. Allergy to sodium hyaluronate. History of other ocular disease for example glaucoma, uveitis. History of contact lenses used. History of use connective tissue disease for example rheumatoid arthritis SLE, Sjogren disease.

Design outcomes

Primary

Measure	Time frame
Dry eyes indicating 2 time observation after medicinal delivered and 1 mount after Tear osmolarity,Dry eyes indicating 2 time observation after medicinal delivered and 1 mount after The non-invasive tear film break-up time,Dry eyes indicating 2 time observation after medicinal delivered and 1 mount after Oxford grading scale,Dry eyes indicating 2 time observation after medicinal delivered and 1 mount after Ocular Surface Disease Index score	—

Measure

Time frame

Dry eyes indicating 2 time observation after medicinal delivered and 1 mount after Tear osmolarity,Dry eyes indicating 2 time observation after medicinal delivered and 1 mount after The non-invasive tear film break-up time,Dry eyes indicating 2 time observation after medicinal delivered and 1 mount after Oxford grading scale,Dry eyes indicating 2 time observation after medicinal delivered and 1 mount after Ocular Surface Disease Index score

—

Secondary

Measure	Time frame
Side effect Interview after 1 mount medicinal delivered Patient interview	—

Countries

Thailand

Contacts

Public ContactSujintana Tanterdtham

Vejthani Hospital

paojung187@gmail.com0814060825

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026