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Frequently Asked Questions About Clinical Trial Studies
What is a Clinical Research Trial?
Clinical research trials are medical- or health related research studies performed with humans. These studies follow a predefined
Protocol – written plan of action.
How does a clinical research trial evaluating a new investigational medication work?
Your health will be checked at the beginning of the trial. Then you’ll receive specific instructions for what you will need to next. You will be monitored carefully throughout the trial, and once the trial is completed your health will be checked again.
How will my safety be protected during the trial?
Clinical trials must conform to the same ethical and legal standards that regulate all medical practice in this country. In addition, most clinical research is regulated by the federal government with built-in safeguards to protect participants. The trial must follow the carefully controlled protocol that details what researchers do in the study.
Who monitors this research?
The US Food and Drug Administration (FDA) is the federal agency that reviews the earliest laboratory tests to determine if the drug is safe enough to test on humans. When a drug company receives approval to go forward, the company must provide the FDA with very detailed information about how the clinical research will be conducted.
Participants are the top priority for everyone concerned with a clinical trial. The study team members at each site follow the protocol document, which guides their activities exactly. The FDA also requires that a clinical protocol must be reviewed by and Investigational Review Board (IRB) composed of doctors, scientists, clergy, and other community representatives. This ensures that all participants will be treated with care and respect throughout the trial.
Will I be reimbursed for my time and travel?
Yes. Generally clinical trial participants are reimbursed for their time and travel.
Can I leave a clinical trial after it is begun?
Yes. You can withdraw from a trial at any time. If you withdraw, you will be asked to notify the study team (the doctor and/or study coordinator), give your reason for leaving, and follow through with the clinical trial exit process.
What if I need to see another doctor during the clinical trial period?
If possible, before the visit to the other doctor, notify your study doctor or nurse and explain the reason for the visit. If another medication is prescribed during the visit, let your study coordinator know.
We are currently offering the following studies to our patients. If you would like to participate in these research studies
And someone
from our research team will contact you within 24 hours.
DRY EYE CLINICAL RESEARCH STUDY
Have you been diagnosed with dry eye?
We are seeking qualified participants for an upcoming clinical research study that will last approximately35 days. If you have dry eye, you may qualify for this study.
Benefits of participation include:
• Study related exams and study medication provided at no cost.
•Compensation for your time and travel
• No medical insurance is required for participation in this study.
PURPOSE OF THE PINK EYE STUDY.
The purpose of this study is to investigate the safety and effectiveness of gatifloxacin 0.5%
eye drops in the treatment of bacterial conjunctivitis. Gatifloxacin 0.5% will be compared
with its vehicle (the study drug without the active ingredient). The use of these eye drops is
investigational. Investigational means that this use has not been approved by the United States
Food and Drug Administration (FDA).
Approximately 460 to 500 subjects will participate in this study. Each subject will be assigned
randomly (by chance, like flipping a coin) to one of the two eye drop medications. There is an
equal chance that you will receive either:
• gatifloxacin 0.5% ophthalmic solution, or
• gatifloxacin vehicle (the study drug without the active ingredient).
Neither you nor the study doctor will know which of the eye drop medications is given to you,
but in the event of an emergency that information can be obtained.
PURPOSE OF THE GLAUCOMA RESEARCH.
The purpose of this research is to see if the investigational device, the SOLX Gold Shunt, is safe and effective
in lowering the pressure within the eye when surgically implanted.
This study has been designed to statistically evaluate the clinical performance of the SOLX Gold Shunt when
compared to the Ahmed™ Glaucoma Valve. FDA approved the Ahmed™ shunt several years ago, and glaucoma
specialists have implanted many of them in the same kinds of patients who would qualify for this study.
Available shunts can be reasonably safe and effective for qualified glaucoma patients, but many complications
can occur with these shunts that are associated with the bleb (a rounded bulge of fluid). These include:
• Infection,
• Rise in IOP,
• Unusual sensations,
• Decreased visual acuity (inability to see clearly and/or,
• Possibly loss of the eye.
The SOLX Gold Shunt is designed to lower IOP without requiring the formation of a bleb.
PURPOSE OF THE GLAUCOMA STUDY.
The purpose of this research if to see if the investigational device; i.e., the Titanium Sapphire Laser is safe and
effective in lowering the pressure within the eye when used on the trabecular meshwork by the investigating
doctor. This study has been designed to statistically evaluate the clinical performance (safety and effectiveness)
of the Titanium Sapphire Laser
In this study the performance of the Titanium Sapphire Laser will be compared to the trabeculoplasty done with
an Argon laser. Over the past two decades Argon lasers have been use in trabeculoplasty procedures to lower
intraocular pressure. There are risks (side effects, adverse reactions) associated with laser trabeculoplasty, as with
any surgical procedure.
The design of this study is to randomize subjects to either one treatment (Titanium Sapphire Laser) or the other
(Argon Laser). In this design you have an equal chance of having the Titanium Sapphire Laser or the Argon Laser
used. Your assignment to either group will be determined by chance alone.
Subjects will have the surgery with either laser in one eye only (the “operated eye”). The other eye (“fellow eye”)
will serve as a control and will not be eligible to receive surgical treatment for at least 6 months. All glaucoma
medications used prior to the surgery will be continued. Adjustments to the medications used, frequency of use,
or dosage level may be made at the discretion of the investigating physician.
You will be expected to return for evaluations of the pressure in your eyes and of your recovery and progress on
a defined and compulsory schedule. You must have all eye pressures taken at approximately the same time of day
at each visit. The scheduled visits will be discussed with you before you agree to participate in this study. After the
surgery, the 6 required examinations are scheduled at periodic intervals over 12 months. Five of the visits will take
from 2 to 4 hours each. One of the six visits will only require measurements of your intraocular pressure, and
observations of your eyes’ condition. Depending on the observations at each visit, additional visits may be required.
In the initial phase of the study 160 subjects will take part in the study. The study will involve up to 10 clinics in the
United States and in Europe.
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