Comparison of the treatment effect of preservative-free vs preserved eye drops in patients with dry eye syndrome

Comparison of antioxidant and inflammatory cytokine activities in tears of patients with dry eye syndrome treated with preservative-free vs preserved eye drops

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13765551

Enrollment

100

Registered

2014-02-05

Start date

2012-09-01

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 Dry eye syndrome

Interventions

Permuted blocks were obtained using a computer-based random code generator (Research Randomizer

http://randomizer.org/). 50 patients (Group 1) were treated four times with preservative-free 0.1% sodium hyaluronate and 0.1% fluorometholone for the first month and preservative-free 0.1% sodium hy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible patients were at least 21 years of age and had a diagnosis of dry eye syndrome refractory to conventional management. Inclusion criteria were: 1. Schirmer test (without anesthesia) of 5 mm/5 minutes in at least one eye 2. Low tear film break-up time (tBUT) (<5 seconds) 3. Mild superficial punctate keratitis, defined as a corneal punctate fluorescein staining score of =1 in either eye (scale 0 [none] to 3 [severe]); and one or more moderate (=2) dry eye related symptoms, including itching, burning, blurred vision, foreign body sensation, dryness, photophobia, soreness, or pain.

Exclusion criteria

Exclusion criteria: Patients were excluded if they had: 1. A history of any ocular disorder including injury, infection, non-dry-eye ocular inflammation, trauma, or surgery within the prior 6 months 2. Were receiving concurrent treatment that could interfere with interpretation of the study results 3. Had any uncontrolled systemic disease or significant illness; or were pregnant, lactating, or considering becoming pregnant. 4. Patients could be discontinued before the completion of the study because of adverse events, pregnancy, protocol violations, lack of efficacy, or administrative or personal reasons.

Design outcomes

Primary

Measure	Time frame
1. Ocular surface disease index (OSDI) 2. Corneal fluorescein staining 3. Schirmer tear test (without anesthesia) 4. Tear film break-up time (tBUT) 5. Symptom score of dry eye 6. Impression cytology Measured at baseline, 1, 2 and 3 months.	—

Secondary

Measure	Time frame
Antioxidant and Inflammatory cytokine activities in tears measured by ELISA at baseline, 1, 2 and 3 months.	—

Countries

Korea, South

Outcome results

None listed

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