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

ALLOGENEIC VERSUS AUTOLOGOUS SERUM EYE DROPS: A DOUBLE-BLIND RANDOMIZED CROSS OVER TRIAL - Allogeneic versus autologous serum eye drops

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44085

Enrollment

Registered

2016-11-10

Start date

2017-06-26

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Dry eye syndrome

Interventions

treatment with autologous or allogeneic serum eye drops

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
OSDI score.	—

Secondary

Measure	Time frame
- tear production (Schirmer's test) - tear break up time - number of corneal punctates - user friendliness of the Meise eye drop disposable	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)