Clinical Research
Innovative care.
Life-changing results.
Far-reaching implications.
At OC Surgical, we are committed to stay on the leading edge of eye care. One of the many ways in which we are successful at that, is by participating in physician controlled clinical research studies. Through our collaboration with various healthcare partners, the physicians of OC Surgical have contributed to major advances in eye care by developing more effective therapies and improvements in various ophthalmic devices and surgical techniques. Please contact us to learn more about how you can participate in an ongoing clinical study at OC Surgical.
Sierra Clinical Trials Research Organization
SCTRO is a dedicated practice research group that offers clinical site, recruitment, and CRO services. Established in 2010, SCTRO has conducted over 100 clinical trials in Ophthalmology, Optometry, Internal Medicine, Physical Medicine, and Visual Rehabilitation. The foundation of our success at SCTRO has and continues to center around patient safety, excellent clinical care, and meeting study enrollment goals in a timely manner.
Dry Eye Alliance
The SCTRO Global Dry Eye Alliance is comprised of a network of therapeutic experts who can provide the specialized knowledge required to address the unique challenges of developing dry eye treatments. We can provide guidance support for:
1. Diagnoses and treatment of ocular surface diseases
2. Currently available anti-infective drugs; their mode of action, efficacy and safety
3. Specific risks of anti-infective drug development and how to manage them
4. Specialized knowledge of clinical trial methodology and efficacy assessment methods
5. Relationships with key opinion leaders
6. Access to a well-established global network of investigators in dry eye disease, dysfunctional tear syndromes, and ocular surface reconstruction
Services
At SCTRO, we provide multi-service offerings as it relates to the following:
1. Protocol Design Consulting
2. Product Development Consulting
3. Medical Writing
4. Subject Recruitment Strategies
FAQs
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A clinical trial is used to test new products and existing medications for new treatments. At the SCTRO Unit, we work with some of the world’s leading pharmaceutical and biotechnology companies on Phase I/II studies to test things like; how a drug is absorbed into the body, how a drug reacts to other medications and how the drug is affected by food.
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Potential risks and benefits vary from study to study. However, if you are interested in participating in a specific study, potential risks and benefits will be explained to you before you give your consent to participate. You will also be able to ask questions of our medically trained staff if you have any concerns that are not addressed.
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No, in order to provide the level of information needed you can only take part in one study at a time. For each drug trial to provide the level of information needed to understand how a new medicine works, volunteers can only take part in one study at a time with 1-3 months in between the end of one trial and the start of another.
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That's no problem. Our medical trials are voluntary, so if you have a change of heart after you've applied, at the screening session or even during the clinical trial you are free to withdraw your consent. If you’ve already started the clinical trial our doctors may want you to come back for a visit, just to check that the drug is out of your system.
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Depending on the type of study you’re volunteering for, there are certain conditions we may ask you to meet to ensure accurate trial results. These could include restrictions on exercise, smoking, medications and alcohol. We’ll give you full details before you apply to take part in a study so you’ll always know what’s expected.
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Men and women, age 18 and older. The studies conducted at our clinics generally require that you are at least 18 years of age. Medical eligibility requirements vary with each clinical study. Phase I clinical studies require that you meet strict healthy qualifying criteria determined by the study protocol - this can include restrictions on smoking, medications, recreational drug use and alcohol. Phase II/III clinical studies also have strict qualifying criteria similar to Phase I clinical studies, with the exception of the need for having certain medical conditions.
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Phase I clinical research studies require one or more residential stays at the research clinic, and may require multiple outpatient visits and at home dosing. The length of the confinement periods and number of outpatient visits are dependent upon the requirements of each study. When you stay at the research clinic, you will have multiple blood draws, physical exams and vital sign checks. Between procedures, you may have time to read, study, watch TV, play games, etc. Other recreational items such as a pool table, DVDs, board games and internet service may be available but vary based on the research clinic location.
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This varies for each medical trial depending on what medication you are on and the trial design. Each clinical trial has different requirements for volunteers. Most healthy volunteer trials require just that – healthy volunteers – and therefore if you are taking long-term medication, you may not be suitable. Often if you are on short-term treatment, for example, a week of antibiotics for a throat infection, you would be able to take part once you have finished the course of medicine and the condition it was treating has cleared up.
However, research is also conducted in patient groups who may need to take medication to manage their condition. In this case it will depend on the trial requirements, but the trial will often be designed to allow patients to still take their normal medicines.
As this changes from trial to trial, please contact our recruitment team and they can discuss what clinical trials will work for you. -
Yes, safeguarding your information is a key part of the relationship of trust between the study team and patient. Depending on the type of study, patient identifiers such as names, birthdates, and residences, etc. will be collected. At SCTRO, we take the following steps/measures to ensure patient privacy and confidentiality are maintained and adhered:
1. Access to research data is restricted to a “need to know” or “as necessary” basis.
2. Measures to maintain confidentiality are also incorporated in the study protocol as well as the informed consent.