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

A dosing study of the ForSight Ocular System on Safety and Efficacy in Anterior Segment Eye Disease in Australia

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000960853

Enrollment

Registered

2012-09-06

Start date

2012-10-30

Completion date

2013-10-29

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

Certain prior eye surgeries with different time windows for exclusion based on type of eye surgery.

Outcome results