Condition category
Eye Diseases
Date applied
30/11/2006
Date assigned
19/01/2007
Last edited
19/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.cibavision.jp

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

Publication citations

Additional files

Editorial Notes