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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612000365864
• Date of registration: 29/03/2012
• Prospective Registration: Yes
• Primary sponsor: ForSight VISION5, Inc
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 02/04/2012
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12612000365864.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial;
• Phase: Phase 1

Countries of recruitment

Latvia

Contacts

• Name: Ms Anne Rubin

• Name: Ms Anne Rubin

Key inclusion & exclusion criteria

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.
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.

Age minimum: 21 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anterior segment eye disease;
Anterior segment eye disease

Eye - Diseases / disorders of the eye

Intervention(s)

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).

Primary Outcome(s)

Safety as assessed in terms of ocular and systemic AEs as determined by eye exam. AEs may include erythema, corneal scratch, lid edema.[Day 0,7,14,28,35, Month 2, Week 10, Months 3,4,5,6,7.]

Secondary Outcome(s)

Efficacy as measured by tonometry.[Day 0,7,14,28,35, Month 2, Week 10, Months 3,4,5,6,7.]

Mechanical device design acceptability as measured by patient comfort questionnaires designed by ForSight.[Day 0,7,14,28,35, Month 2, Week 10, Months 3,4,5,6,7.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

ForSight VISION5, Inc