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Trial registered on ANZCTR


Registration number
ACTRN12612000960853
Ethics application status
Approved
Date submitted
6/09/2012
Date registered
6/09/2012
Date last updated
19/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Dosing Study of the V501 Product - Protocol 503: An Efficacy Study comparing two Doses of the V501 Product in Patients with certain Anterior Segment Eye Diseases
Scientific title
A dosing study of the ForSight Ocular System on Safety and Efficacy in Anterior Segment Eye Disease in Australia
Secondary ID [1] 281179 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior segment eye disease 287345 0
Condition category
Condition code
Eye 287683 287683 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 one of two 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. One 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. One dose will start under 50 mcg/day and will decline toward 0 mcg/day by end of study period.
Intervention code [1] 285629 0
Treatment: Drugs
Intervention code [2] 285630 0
Treatment: Devices
Comparator / control treatment
Two doses will be used for a comparative dosing study. One 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. One dose will start under 50 mcg/day and will decline toward 0 mcg/day by end of study period.
Control group
Dose comparison

Outcomes
Primary outcome [1] 287926 0
Mean IOP using Goldman tonometry during morning, noon, and afternoon at Screening, Roll-in, Day 0, 2 week, 6 week, 12 week, 16 week (and for higher dose) Months 5 and 6.
Timepoint [1] 287926 0
In-office visits at Day 0, 2 week, 6 week, 12 week, 16 week (and for higher dose) Months 5 and 6.
Secondary outcome [1] 299064 0
Safety will also be assessed in terms of ocular and systemic AEs as determined by eye exam. AEs may include erythema, corneal scratch, lid edema.
Timepoint [1] 299064 0
In-office visits at Week 16 (lower dose) or Month 6 (higher dose) and either at Screening (if on standard medical therapy prior to study start) or 4 weeks after study product on standard medical therapy.
Secondary outcome [2] 299773 0
Efficacy as measured by ocular tonometry at 16 weeks (lower dose) or 6 months (higher dose)and either at Screening with standard medical therapy or at 4 weeks with standard medical therapy.
Timepoint [2] 299773 0
16 weeks (lower dose) and 6 months (higher dose) and standard medical therapy either at Screening or 4 weeks after use of study product.

Eligibility
Key inclusion criteria
1. Male or female, at least 18 years of age.
2. Diagnosis of certain anterior segment eye diseases in eligible eye(s).
3. Current treatment with monotherapy drops for anterior segment eye disease with a controlled IOP less than or equal to 18 mmHg in both eyes based on measurement at screening or review of medical record measurements.
4. Other criteria as listed in Protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Certain prior eye surgeries with different time windows for exclusion based on type of eye 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)
Patients enrolled earlier in study will be enrolled starting with lower dose; patients enrolled later will be enrolled with higher dose.
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
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
30/10/2012
Date of last participant enrolment
Anticipated
Actual
29/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285950 0
Commercial sector/Industry
Name [1] 285950 0
ForSight VISION5, Inc
Country [1] 285950 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] 284774 0
None
Name [1] 284774 0
Address [1] 284774 0
Country [1] 284774 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287985 0
Bellberry HREC
Ethics committee address [1] 287985 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 287985 0
Australia
Date submitted for ethics approval [1] 287985 0
24/08/2012
Approval date [1] 287985 0
27/08/2012
Ethics approval number [1] 287985 0
2012-07-960

Summary
Brief summary
Dosing study of sustained release Ocular System for treatment of Anterior Segment Eye Disease to determine Safety and Efficacy of the ForSight V501 Product.
Trial website
Trial related presentations / publications
In process, not yet submitted for publication.
Public notes

Contacts
Principal investigator
Name 34676 0
Ms Please contact ForSight VISION5 for additional information
Address 34676 0
Please contact ForSight VISION5 for additional information
Country 34676 0
Australia
Phone 34676 0
+1-650-325-2050
Fax 34676 0
Email 34676 0
[email protected]
Contact person for public queries
Name 17923 0
Anne Rubin
Address 17923 0
ForSight VISION5
191 Jefferson Drive
Menlo Park, CA 94025
Country 17923 0
United States of America
Phone 17923 0
+1-650-325-2050
Fax 17923 0
Email 17923 0
[email protected]
Contact person for scientific queries
Name 8851 0
Anne Rubin
Address 8851 0
ForSight VISION5
191 Jefferson Drive
Menlo Park, CA 94025
Country 8851 0
United States of America
Phone 8851 0
+1-650-325-2050
Fax 8851 0
Email 8851 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.