Modification of ocular graft-versus-host disease development by early local Cyclosporin A application in patients after donor stem cell transplant.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28561

Enrollment

102

Registered

2010-11-09

Start date

2010-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Ocular GVHD Preventive treatment Topical Cyclosporine A

Interventions

Arm 1: Cyclosporine 0.05% eye drops (Restasis) 2 times a day in each eye (51 patients)

Arm 2: Vidisic PVP ophtiole eye drops 2 times a day in each eye (51 patients).

Eligibility

Inclusion criteria

Inclusion criteria: Patients > 18 yrs who have undergone donor stem cell transplant for haematological malignancy or bone marrow failure disorder.

Exclusion criteria

Exclusion criteria: 1. History of Sjögren’s syndrome; 2. Documented dry eye prior to stem cell transplantation / significant non-GVHD ocular problems; 3. History of non-compliance.

Design outcomes

Primary

Measure	Time frame
To investigate the potential efficacy of topical cyclosporine A 0.05% (Restasis) application in preventing ocular surface disease in ocular chronic GVHD in patients who have undergone donor stem cell transplantation an compare this to the effect of preventive treatment with Vidisic PVP Ophtiole eye drops.	—

Secondary

Measure	Time frame
1. Evaluate the safety and frequency of side effects of Cyclosporine A; 2. Evaluate the correlation of ocular GVHD symptoms in relation to GVHD symptoms in general.	—

Contacts

Public ContactAnjo Riemens

P.O. Box 85 500

J.A.Riemens@umcutrecht.nl+31 (0)88 7559646

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)