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

Completed

Conditions: Dry eye syndrome
Eye Diseases

Registration Number: ISRCTN13765551

Lead Sponsor: Bucheon St. Mary's Hospital (Korea, South)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures