Pilot Study of the V501 Product - Protocol 502: A pilot study of the ForSight Ocular System on Safety and Efficacy in Anterior Segment Eye Disease in Latvia
ForSight VISION5, Inc
30 participants
Apr 2, 2012
Interventional
Conditions
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. Note: Similar pilot study is being run in Australia: http://www.ANZCTR.org.au/ACTRN12612000362897.aspx
Eligibility
Inclusion Criteria8
- 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.
Exclusion Criteria1
- 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.
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Interventions
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. The design for this study (Protocol 502) may possibly be influenced by the progress of our organisation’s corresponding, ongoing, Australian study (Protocol 501) which began in 2011 (see: http://www.ANZCTR.org.au/ACTRN12612000362897.aspx).
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12612000365864