Contact information
Type
Scientific
Primary contact
Dr Junko Ogawa
ORCID ID
Contact details
Shinanomachi 35 Shinjuku ku
Keio Univ Sch Med
Dept Ophthalmology
Tokyo
160-8582
Japan
junoga1102@yahoo.co.jp
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
Acronym
Study hypothesis
Bandage contact lenses have favourable effects on the occular surface disease status in severe dry eye patients with chronic Graft-Versus-Host Disease (cGVHD).
Ethics approval
US Food and Drug Administration (FDA) approved contact lens material used for the study. Therapeutic contact lenses are not regarded as medical devices in Japan. According to our regulations, when contact lenses are deemed essential for therapeutic purposes by an ophthalmologist, permission from the university or hospital is not required.
Study design
Retrospective, consisting of chart review of GVHD patients who received therapeutic contact lenses wear. Please note that chart reviews started in September 1, 2006 and will be finalised by spring next year.
Primary study design
Observational
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Chronic graft versus host disease
Intervention
Silicone hydrogel Contact Lens use. Patients wore contact lenses continuously and
replaced their contact lenses for every week to once in four weeks. Only patients with more than six months of follow up were included.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Pain relief
Secondary outcome measures
Vital staining score
Overall trial start date
01/09/2006
Overall trial end date
30/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Severe cGVHD dry eye subjects with fibrotic lid changes and trichiasis refractory to treatment with non-preserved artificial tears
2. Autologous serum eye drops
3. Bilateral punctal occlusion
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
10 patients
Participant exclusion criteria
1. Mild cGVHD patients
2. cGVHD
Recruitment start date
01/09/2006
Recruitment end date
30/04/2007
Locations
Countries of recruitment
Japan
Trial participating centre
Shinanomachi 35 Shinjuku ku
Tokyo
160-8582
Japan
Sponsor information
Organisation
Ciba Vision (Japan)
Sponsor details
Tennoz Central Tower 13
2-2-24 Higashi Shinagawa
Tokyo
140-0002
Japan
junoga1102@yahoo.co.jp
Sponsor type
Industry
Website
Funders
Funder type
Other
Funder name
Contact lenses were donated by CIBA vision. Costs incurred by vital staining, and
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
slit lamp examinations were covered by social insurance.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary