Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000021077
Ethics application status
Approved
Date submitted
24/11/2009
Date registered
8/01/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Evaluation of the AqueSys Implant for the Treatment of ocular hypertension and open angle glaucoma
Scientific title
Clinical evaluation of the safety and effectiveness of the AqueSys implant in participants with poorly controlled intraocular pressure
Secondary ID [1] 252051 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular hypertension and open angle glaucoma 252281 0
Condition category
Condition code
Eye 252459 252459 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The AqueSys Implant is implanted in the eye and is intended for the treatment of open angle glaucoma and ocular hypertension. The preloaded needle is inserted through the cornea and the needle is directed across the anterior chamber and implanted in the target quadrant of the eye. The implantation procedure will take approximately 30 minutes. The implant will remain permanently or until it is removed.
Intervention code [1] 241525 0
Treatment: Devices
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253330 0
Safety and Effectiveness. Effectiveness will be evaluated by comparing baseline intraocular pressure values to postoperative values.
Timepoint [1] 253330 0
Post operative values taken at 1 day, 1 week, 2 week, 1 month, 3 month, 6 month, 9 month and 1 year.
Secondary outcome [1] 262408 0
Suitability of study procedure for use based on the successful application of the device.
Timepoint [1] 262408 0
Assessed during operative period.

Eligibility
Key inclusion criteria
Subjects with poorly controlled intraocular pressure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Angle Closure Glaucoma
2. Congenital or other secondary glaucomas developed as a complication of other medical conditions

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244077 0
Commercial sector/Industry
Name [1] 244077 0
Aquesys Inc
Country [1] 244077 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Aquesys Inc
Address
26970 Aliso Viejo Parkway, Suite 200, Aliso Viejo, California 92656
Country
United States of America
Secondary sponsor category [1] 251424 0
Commercial sector/Industry
Name [1] 251424 0
PCRG
Address [1] 251424 0
PACIFIC CLINICAL RESEARCH GROUP
COURIER ADDRESS:
1 CASSINS AVENUE, SUITE G03
NORTH SYDNEY, NSW 2060
AUSTRALIA
Country [1] 251424 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The primary objective of the study is to evaluate the safety and effectiveness of the AqueSys Implant for the treatment of ocular hypertension and open angle glaucoma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30487 0
Address 30487 0
Country 30487 0
Phone 30487 0
Fax 30487 0
Email 30487 0
Contact person for public queries
Name 13734 0
Rupali N. Jobanputra
Address 13734 0
Rupali N. Jobanputra Manager, Clinical Affairs AqueSys, Inc.
26970 Aliso Viejo Parkway, Suite 200, Aliso Viejo, California 92656.
Country 13734 0
United States of America
Phone 13734 0
+1 (949) 450-0250 x223
Fax 13734 0
+1 (949) 425-1012
Email 13734 0
[email protected]
Contact person for scientific queries
Name 4662 0
Rupali N. Jobanputra
Address 4662 0
Rupali N. Jobanputra Manager, Clinical Affairs AqueSys, Inc.
26970 Aliso Viejo Parkway, Suite 200, Aliso Viejo, California 92656
Country 4662 0
United States of America
Phone 4662 0
+1 (949) 450-0250 x223
Fax 4662 0
Email 4662 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.