The efficacy of diquafosol eyedrops in dry eye syndrome

Additive effect of preservative-free sodium hyaluronate 0.1% in treatment of dry eye syndrome with diquafosol 3% eyedrops

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN44290046

Enrollment

150

Registered

2014-05-27

Start date

2013-05-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Dry eye syndrome Eye Diseases Other disorders of lacrimal gland

Interventions

Participants were randomized to one of the following three groups: Group 1 (50 patients, 50 eyes) were treated with preserved sodium hyaluronate 0.1% eyedrops (Lacure, Samil, Seoul, Korea) (four times

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Low tear film break-up time (tBUT) (<5 seconds) 2. Low Schirmer I score (10 mm/5 minutes without anesthesia) 3. Mild corneal punctate fluorescein staining (staining score of =1) in either eye (scale 0 ~ 3) 4. At least 21 years old

Exclusion criteria

Exclusion criteria: 1. History of ocular injury, infection, non-dry eye ocular inflammation, trauma, or surgery within the prior 6 months 2. Presence of uncontrolled systemic disease

Design outcomes

Primary

Measure	Time frame
1. Ocular surface disease index (OSDI) scoring 2. tBUT 3. Schirmer I test (without anesthesia) All outcomes were measured before treatment and at 1, 2 and 3 months after the start of treatment.	—

Secondary

Measure	Time frame
1. Corneal fluorescein staining 2. Conjunctival impression cytology All outcomes were measured before treatment and at 1, 2 and 3 months after the start of treatment.	—

Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026