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Research FAQ

Q: What is a clinical trial?

A clinical trial is a research study in which volunteers receive investigational treatments monitored by the FDA and under the supervision of ophthalmologists and other research professionals. The treatments are developed by companies who select qualified physicians to conduct clinical trials in order to determine the benefits of investigational product. 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 phases involve a larger number of volunteers.

Q: Who can participate in Clinical Trial?

All clinical trials have guidelines about who can participate. Using inclusion and exclusion criteria is an important principle of medical research that helps to 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 2 years

Q: What are the ongoing and current study treatments?

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.

Q: How do clinical trials work?

Male and female subjects, 22 years of age or older, will be screened for enrollment in multi-site research study. Subjects who qualify for the study will be treated according to the study and participate in the study for 2 years minimum. Several exams will be performed at study visits such as: updating medical history, Visual Field, Vision Check, eye pressure check, examining the inside front of your eye (anterior chamber), examining the back of your eye (the retina) and imaging of your eye.

Q: What are the benefits and risks of joining a clinical trial?

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

Benefits:

  • Play an active role in their own 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 serious 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

Q: How often will I be seen?

Participants receive a medical examination and their medical histories are reviewed by the study ophthalmologist, optometrist and research staff members before and once enrolled in the study. The volunteer’s health will be continue to be monitored for 24 months and after the trial. Please Note: volunteers may withdraw from a study at any time for any reason.

Q: How much will it cost?

Most study related costs will be covered in full by the study sponsor and any potential expenses will be outlined by your study coordinator. Some studies may reimburse for travel costs or pay small stipends for certain visits.

Q: Does information remain confidential and private?

Access to personal information is usually available to the ophthalmologist, optometrist and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and the sponsors will have access to personal information.

Q: What happens after the trial?

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