Clinical Studies FAQ

Our clinical trials are open to all patients who fit specific qualifications. Read our frequently asked questions below to learn more about our clinical studies.

A clinical trial is a research study in which volunteers receive investigational treatments monitored by the FDA under the supervision of ophthalmologists and other research professionals. 

Companies that develop the treatments select qualified physicians to conduct clinical trials to determine the benefits of the investigational products. Clinical trials are usually conducted in three (I, II, III) phases. Only a small number of people participate in phase I trials, while the later stages involve a larger number of volunteers.

All clinical trials have specific guidelines about who can participate. Using inclusion and exclusion criteria is an essential medical research principle that helps produce reliable results.

Inclusion Criteria:

  • 22 years or older
  • Diagnosed with mild to moderate Primary Open Angle Glaucoma
  • Intraocular pressure of 18mmHg or higher
  • On 1 to 3 topical ocular medications or not on topical ocular medication due to intolerance
  • Willing to follow up and attend research visits for the next two years

Visco 360: https://clinicaltrials.gov/ct2/show/NCT02928289?term=visco+360&rank=1

InnFocus: https://clinicaltrials.gov/ct2/show/NCT01881425?term=innfocus&rank=2

Contact Corinna or Iryna at (479) 442-8653 Ext 1003 or 1004 for more information on currently enrolling trials.

Male and female subjects, 22 years or older, will be screened for enrollment in the multi-site research study. Subjects who qualify for the clinical study will be treated and participate in the study for two years minimum. 

Doctors perform several exams such as updating medical history, Visual Field, Vision Check, eye pressure check, examining the inside front of your eye (anterior chamber) and the back of your eye (the retina), and imaging your eye.

Clinical trials are well designed, well-executed, and are the best treatment approach for eligible participants to:

Benefits:

  • Play an active role in their healthcare
  • Gain access to new research treatments before they are widely available
  • Obtain expert medical care at leading healthcare facilities
  • Help others by contributing to medical research

Risks:

  • There may be unpleasant or severe side effects
  • Treatment may not be effective for the participant
  • The protocol may require more of their time and attention, including trips to the study site

The study ophthalmologist, optometrist, and research staff members review participants receive a medical examination and their medical histories before and once enrolled in the study. The volunteer’s health will continue to be monitored for 24 months after the trial. Please note that volunteers may withdraw from a study at any time.

The study sponsor will cover most study-related costs in full, and your study coordinator will outline any potential expenses. Some studies may reimburse travel costs or pay small stipends for certain visits.

Only the study ophthalmologist, optometrist, and research team have access to personal information. In some circumstances, the IRB overseeing the research and the sponsors will have access to personal information.

After the study phase, the data is collected to determine the drugs and the device’s effectiveness and if there are any side effects. After phase III of a study is complete, researchers submit all data and documentation to the Food and Drug Administration (FDA) for approval.

Are you interested in participating in a current clinical study?

Vold Vision is currently enrolling for multiple FDA clinical studies. If you would like to learn if you are a research candidate, call Vold Vision at 479-442-8653 and ask for Corinna or Iryna.

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