Topical ciclosporin A eye drops for graft rejection

ISRCTN ISRCTN52781697
DOI https://doi.org/10.1186/ISRCTN52781697
Secondary identifying numbers 2000-01800
Submission date
06/08/2009
Registration date
23/09/2009
Last edited
12/04/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rasik Vajpayee
Scientific

Centre for Eye Research Australia
University of Melbourne
Royal Victorian Eye and Ear Hospital
32, Gisborne Street, East Melbourne
Victoria
Melbourne
3002
Australia

Phone +61 (0)3 9929 8368
Email rasikv@unimelb.edu.au

Study information

Study designRandomised controlled double blind interventional single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation of topical ciclosporin A in prevention of corneal graft rejection: a randomised double blind single centre study
Study objectivesTo evaluate the role of ciclosporin A eye drops in cases with corneal endothelial graft rejection after penetrating keratoplasty.
Ethics approval(s)Indian Council of Medical Research, New Delhi, India, approved in 2001
Health condition(s) or problem(s) studiedCorneal graft rejection
InterventionAfter corneal transplantation surgery, patients in the study group will receive 2% ciclosporin eye drops prepared in 1.4% polyvinyl alcohol every six hours for one year. Patients in the control group will receive 1.4% polyvinyl alcohol eye drop (placebo drops) every 6 hours for a similar duration.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Ciclosporin A
Primary outcome measureincidence of occurrence of corneal endothelial graft rejection after high-risk keratoplasty in the study and control group at the end of one year.
Secondary outcome measures1. Incidence of reversal of graft rejection in the study and control group at the end of one year
2. Incidence of occurrence possible side effects of using ciclosporin A eye drops in the study group at the end of one year
Overall study start date01/08/2001
Completion date31/01/2005

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants84 patients
Key inclusion criteria1. Patients greater than or equal to 9 years of age, either sex
2. Eyes undergoing penetrating keratoplasty
3. With two or more quadrants of corneal vascularisation extending at least 2 mm into the cornea
4. Cases of corneal re-grafts
Key exclusion criteria1. Grafts that are not high-risk
2. Pregnant/lactating females
3. Children below 9 years of age
4. Patients who refused to give consent
Date of first enrolment01/08/2001
Date of final enrolment31/01/2005

Locations

Countries of recruitment

  • Australia
  • India

Study participating centre

Centre for Eye Research Australia
Melbourne
3002
Australia

Sponsor information

Indian Council of Medical Research (ICMR) (India)
Research council

V. Ramalingaswami Bhawan
Ansari Nagar
New Delhi
110029
India

Phone +91 (0)11 2658 8895
Email headquarters@icmr.org.in
Website http://icmr.nic.in/home.htm
ROR logo "ROR" https://ror.org/0492wrx28

Funders

Funder type

Research council

Indian Council of Medical Research (ICMR) (India) (ref: 2000-01800)
Government organisation / National government
Alternative name(s)
Indian Council of Medical Research, Government of India, Indian Council of Medical Research (ICMR), New Delhi, ICMROrganisation, भारतीय चिकित्सा अनुसंधान परिषद, Indian Council of Medical Research, New Delhi, ICMR, ICMRDELHI, आई.सी.एम.आर
Location
India

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2010 Yes No