Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000066280
Ethics application status
Not yet submitted
Date submitted
15/01/2009
Date registered
27/01/2009
Date last updated
27/01/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of Caspofungin Eye Drops for the Treatment of Fungal Eye Infections
Scientific title
Ocular Penetration of Caspofungin Eye Drops in the Treatment of Fungal Keratitis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fungal Keratitis 4199 0
Condition category
Condition code
Eye 4409 4409 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One drop of 0.5% Caspofungin eye drops will be administered hourly into the eye that will be operated on (commencing 4 hours before participant's elective surgery).
Intervention code [1] 3914 0
Treatment: Drugs
Comparator / control treatment
No
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5293 0
Penetration of Caspofungin into the aqueous humour of the eye. The concentration of caspofungin in the eyes will be measured using high performance liquid chromatography (HPLC) or liquid-chromatography-mass-spectrometry (LC-MS).
Timepoint [1] 5293 0
An hour after the last dose given. One drop hourly (commencing 4 hours before participant's elective surgery).
Secondary outcome [1] 8909 0
Adequate concentration of caspofungin achieved in the aqueous humour of the eye to treat fungal keratitis. The concentration of caspofungin in the eyes will be measured using high performance liquid chromatography (HPLC) or liquid-chromatography-mass-spectrometry (LC-MS).
Timepoint [1] 8909 0
An hour after the last dose given. One drop hourly (commencing 4 hours before participant's elective surgery).

Eligibility
Key inclusion criteria
Patients attending for elective eye surgery (eg. cataract surgery)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants in whom the use of caspofungin is contraindicated (eg. pregnancy, hypersensitivity to caspofungin or its formulation, risk of clinically significant drug interactions or as per caspofungin's product information guide)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4382 0
Charities/Societies/Foundations
Name [1] 4382 0
Contributing to Australian Scholarship & Sciences (CASS) Foundation
Country [1] 4382 0
Australia
Primary sponsor type
University
Name
Monash
Address
381, Royal Parade, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 3972 0
None
Name [1] 3972 0
Address [1] 3972 0
Country [1] 3972 0
Other collaborator category [1] 532 0
Hospital
Name [1] 532 0
The Royal Victorian Eye & Ear Hospital (RVEEH)
Address [1] 532 0
32, Gisborne Street, East Melbourne, VIC 3002
Country [1] 532 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6431 0
Ethics committee address [1] 6431 0
Ethics committee country [1] 6431 0
Date submitted for ethics approval [1] 6431 0
09/02/2009
Approval date [1] 6431 0
Ethics approval number [1] 6431 0
Ethics committee name [2] 6462 0
Ethics committee address [2] 6462 0
Ethics committee country [2] 6462 0
Date submitted for ethics approval [2] 6462 0
02/02/2009
Approval date [2] 6462 0
Ethics approval number [2] 6462 0

Summary
Brief summary
This proposed study is intended to investigate if the antifungal drug, caspofungin, when applied as an eye drop is able to penetrate into the human eyes. The use of caspofungin as an eye drops in human has never been reported. Caspofungin eye drops are anticipated to safely penetrate into the human eyes when applied as eye drops and to achieve adequate concentrations to treat fungal eye infections.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35090 0
Address 35090 0
Country 35090 0
Phone 35090 0
Fax 35090 0
Email 35090 0
Contact person for public queries
Name 12437 0
Dr David CM Kong
Address 12437 0
Department of Pharmacy Practice
Faculty of Pharmacy and Pharmaceutical Sciences
381, Royal Parade, Parkville, VIC 3052
Country 12437 0
Australia
Phone 12437 0
+61 3 9903 9035
Fax 12437 0
+61 3 9903 9629
Email 12437 0
[email protected]
Contact person for scientific queries
Name 3365 0
Dr David CM Kong
Address 3365 0
Department of Pharmacy Practice
Faculty of Pharmacy and Pharmaceutical Sciences
381, Royal Parade, Parkville, VIC 3052
Country 3365 0
Australia
Phone 3365 0
+61 3 9903 9035
Fax 3365 0
+61 3 9903 9629
Email 3365 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3909Plain language summaryNo Ten participants attending elective anterior segme... [More Details]
4251Study results articleYes Antimicrob Agents Chemother. 2011 Apr; 55(4): 1761... [More Details]

Documents added automatically
No additional documents have been identified.