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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
ACTRN12612000362897
Ethics application status
Approved
Date submitted
23/03/2012
Date registered
29/03/2012
Date last updated
6/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot Study of the V501 Product - Protocol 501: A pilot study of the ForSight Ocular System on Safety and Efficacy in Anterior Segment Eye Disease in Australia
Scientific title
Pilot Study of the V501 Product - Protocol 501: A pilot study of the ForSight Ocular System on Safety and Efficacy in Anterior Segment Eye Disease in Australia
Secondary ID [1] 280201 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior segment eye disease 286141 0
Condition category
Condition code
Eye 286334 286334 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ForSight Ocular System (drug/device combination product) will be placed in eye. Product contains prostaglandin which elutes with varying dose over six month period. Dose is higher at beginning of use of product and gradually declines as drug elutes from product, as is typical for drug-eluting products. Maximum daily dose will not exceed levels tested in prior clinical studies. Dose will start under 100 mcg/day (maximum amount tested in prior clinical use) and will decline toward 0 mcg/day by end of study period.
Intervention code [1] 284530 0
Treatment: Drugs
Intervention code [2] 284539 0
Treatment: Devices
Comparator / control treatment
No control (pilot study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286801 0
Safety as assessed in terms of ocular and systemic AEs as determined by eye exam. AEs may include erythema, corneal scratch, lid edema.
Timepoint [1] 286801 0
In-office visits at Day 0, 7, 14, 28, 29, 35, and Months 3,4,5,6,7.
Secondary outcome [1] 296683 0
Efficacy as measured by ocular tonometry.
Timepoint [1] 296683 0
In-office visits at Day 0, 7, 14, 28, 29, 35, and Months 3,4,5,6,7.
Secondary outcome [2] 296684 0
Mechanical device design acceptability as measured by patient comfort questionnaires designed by ForSight.
Timepoint [2] 296684 0
In-office visits at Day 0, 7, 14, 28, 29, 35, and Months 3,4,5,6,7.

Eligibility
Key inclusion criteria
Subjects who are diagnosed with certain types of anterior segment eye disease in at least one eye.

Subjects with mean deviation on Visual Field of -12 dB or less.

Subjects with no visual field loss within 10 degrees of fixation.

Cup-to-disc ratio of 0.8 or less.

Subjects whom the Investigator deems can be safely washed out of their medications as described in this study.

Females of child-bearing age who are not breast-feeding and who are using an acceptable form of birth control/contraception and plan to continue doing so throughout the study duration.

Subjects currently receiving treatment with a prostaglandin

Subjects who are able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits.
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Certain prior eye surgeries including SLT or filtering surgery within the last three years, patients who have had any ophthalmic surgery within the last three months, or who have had corneal or refractive surgery.

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 1
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 284951 0
Commercial sector/Industry
Name [1] 284951 0
ForSight VISION5, Inc
Address [1] 284951 0
191 Jefferson Drive
Menlo Park, CA 94025
Country [1] 284951 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
ForSight VISION5, Inc
Address
191 Jefferson Drive
Menlo Park, CA 94025
Country
United States of America
Secondary sponsor category [1] 283823 0
None
Name [1] 283823 0
Address [1] 283823 0
Country [1] 283823 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286963 0
Belberry Human Research Ethics Committee
Ethics committee address [1] 286963 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 286963 0
Australia
Date submitted for ethics approval [1] 286963 0
Approval date [1] 286963 0
13/12/2011
Ethics approval number [1] 286963 0
Application No: 2011-09-446-A-1

Summary
Brief summary
Pilot study of sustained release Ocular System for treatment of Anterior Segment Eye Disease to determine Safety and Efficacy of the ForSight V501 Product. Data will be analysed qualitatively, a formal statistical hypothesis is not being tested in this pilot study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33966 0
Address 33966 0
Country 33966 0
Phone 33966 0
Fax 33966 0
Email 33966 0
Contact person for public queries
Name 17213 0
Anne Rubin
Address 17213 0
ForSight VISION5
191 Jefferson Drive
Menlo Park, CA 94025
Country 17213 0
United States of America
Phone 17213 0
+1-650-325-2050
Fax 17213 0
Email 17213 0
trials@forsightv5.com
Contact person for scientific queries
Name 8141 0
Anne Rubin
Address 8141 0
ForSight VISION5
191 Jefferson Drive
Menlo Park, CA 94025
Country 8141 0
United States of America
Phone 8141 0
+1-650-325-2050
Fax 8141 0
Email 8141 0
trials@forsightv5.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary