ALLOGENEIC VERSUS AUTOLOGOUS SERUM EYE DROPS: A DOUBLE-BLIND RANDOMIZED CROSS OVER TRIA

Completed

• Conditions: Dry eye syndrome; corneal lesions; 10021877

• Registration Number: NL-OMON44085
• Lead Sponsor: Sanquin Bloedbank

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- chronic dry eye syndrome
- age 18 or higher
- expected to benefit from SEDs
- can donate sufficient blood to prepare autologous SEDs
- meet the donor guidelines of Sanquin (except for age, donation frequency and hemoglobin concentration)

Exclusion Criteria

- has corneal lesions more than punctates
- has a history of unstable Herpes simplex virus (HSV) keratitis or is treated for HSV keratitis
- currently already uses SEDs
- pregnancy, lactating, or intending the become pregnant in the next 3 months
- unable or unwilling to give informed consent
- active (systemic) microbial infection
- poor venous access

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>OSDI score.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- tear production (Schirmer's test)<br /><br>- tear break up time<br /><br>- number of corneal punctates<br /><br>- user friendliness of the Meise eye drop disposable </p><br>