Clinical Research
Research Interests
Learn more about our strategic areas of research interest. We welcome investigator-initiated trial (IIT) proposals on a variety of areas.
About Investigator-Initiated Trials
Learn about the essential requirements to conduct investigator-initiated clinical research as a third-party sponsor.
Investigator-Initiated Trial Considerations
Submission of a proposal does not guarantee approval or funding. The committee evaluates scientific merit as well as available funding.
FOR THE INVESTIGATOR:
- Therapeutic areas of interest (Cataract, Vit/Ret, Cataract Diagnostics, Femtosecond Laser, Cataract Equipment, Corneal Refractive Surgery, Glaucoma, Contact Lenses, Dry Eye, Ocular Allergy)?
- Previous experience with investigator-initiated trials (IITs)?
- Familiarity with the clinical study registration process (clinicaltrials.gov)?
- Does your current schedule allow for the time required to participate in clinical research?
- Do you have access to a biostatistician and a medical writer?
FOR THE INVESTIGATOR SITE:
- Does your site have an experienced clinical study coordinator?
- Does the site have an adequate patient population to support clinical research?
- Does your site have adequate staff to perform the testing required for a clinical study?
- Does your site have the testing equipment required to perform clinical research?
- Are there any current, ongoing studies at the site that would affect enrollment in new clinical studies?
- Is your site required to use a specific institutional review board (IRB)/ethics committee (EC), or can an independent IRB/EC be used?
- How frequently does your IRB/EC meet?
- What is the typical turnaround time for your IRB? - Other than an IRB/EC, are there other committees that need to review your research?
An IIT concept provides a brief description of the proposed study, including the following:
- The therapeutic area of interest for the proposed study
- Type of device or devices to be evaluated in the study
- A brief description of the population that will be enrolled in the study
- The scientific or medical gap that the proposed study will fill
- The main objective of the study
- If possible, a description of the new information this study will add to what is currently in the literature
- An estimated budget for the study
Synopsis, including the following:
- The study title
- A description of the study type (prospective or retrospective, interventional or noninterventional, single center or multicenter, comparative or observational)
- A background section that outlines why the study is being conducted. It should also include a brief literature review of similar studies and key supporting references
- The hypothesis
- The primary objective or aim of the study
- The primary endpoint and any secondary and exploratory endpoints
- Inclusion and exclusion criteria
- Statistical plan including the sample size along with the sample size justifcation.
- Estimated time for IRB/EC approval
- Estimated study duration
- Publication plan: targeted meetings for abstract submissions and targeted journals for manuscript submission
- The proposed study budget Items to submit/upload:
- Curricula vitae for the investigator(s)
- Current year’s W-9 form for the sponsoring entity
Components of a budget for a prospective study:
- Study costs:
- Essential documentation prep (protocol, informed consent, etc)
- IRB/EC submission costs
- Biostatistics/data management costs
- Medical writing costs (manuscript/final report, abstracts, presentation prep)
- Open access fee (if applicable) for journal publication - Patient costs:
- Study coordinator fees (recruitment costs, informed consent, recruitment, retention)
- Study procedure costs (exams, VAs, refractions, questionnaires, etc)
Note: Only procedures that are not covered by third-party payers can be included in the budget
Components of a budget for a retrospective study:
- Study costs:
- IRB/EC submission costs
- Data management and biostatistician costs
- Medical writing costs (manuscript/final report, abstracts, presentation prep)
- Open access fee (if applicable) for journal publication - Clinical costs:
- Clinical study coordinator
- Additional staff time (if necessary)
Submit an Investigator-Initiated Trial (IIT) Proposal
The committee evaluates proposals according to their scientific merit, alignment with our areas of research interest, and available funding.
ALCON SPONSORED CLINICAL TRIAL
Are you interested in participating in an Alcon-sponsored clinical trial? Alcon conducts clinical trials worldwide to evaluate the safety and effectiveness of our products.
Frequently Asked Questions
Whether you practice in a private setting or an academic center, Alcon Medical Affairs welcomes the opportunity to connect with interested researchers. Simply fill out the form below with your details and a member of our Medical Affairs team will be in touch to provide you with more information about research opportunities at Alcon.
Our leadership is grounded in cutting-edge innovation and breakthrough technology, transforming the way we treat eye diseases and eye conditions. We have the widest array of eye care offerings in the industry, with products organized into three areas of focus: surgical, vision care, and dry eye/ocular health. Alcon believes in the need to support ethical independent clinical research conducted by qualified third-party investigators via investigator-initiated trials (IITs), complementing Alcon-sponsored research. To this end, IITs help us explore new opportunities to address unmet real-world medical needs. The investigator has responsibility for study conception, design, operational execution, data handling, data analysis and interpretation, subsequent reporting and publication, and ensuring compliance with all local laws and regulations.
Alcon is open to working with new scientific partners. As part of the application process, however, Alcon is looking to support IIT concepts submitted by third-party sponsors/investigators who are able to demonstrate clear evidence of high ethical and scientific standards as this relates to clinical research in human subjects. For more information, please fill out the form below and a member of our team will provide more information about the IIT process.
We are committed to supporting a substantial amount of clinical research in order to enhance patient care and the practice of medicine around the world. Hence, IITs are conducted by qualified investigators from across the globe. Our Alcon medical colleagues aim to exchange scientific/educational information with health care professionals as experts to enhance the practice of medicine. Our medical colleagues will respond to investigator-expressed interests to address scientific interests and avoid unintended duplication in areas where known research is being undertaken. Contact us for more information.
Our medical affairs team employs rigorous ethical and scientific standards when engaging and reviewing study proposals from third-party independent sponsors, including evaluating investigator qualifications and institutional site capabilities. Alcon will consider, on a case-by-case basis, whether to encourage development of local sponsor capabilities in Good Clinical Practice (GCP) through an appropriate credible third-party/stakeholder, if local policy and regulations permit.
Recent Scientific Publications
GLAUCOMA
The Rationale for Applying a Visual Field Rate of Progression Analysis Using a Hierarchical, Censored, Bayesian Model to the 5-Yeah HORIZON Data
GLAUCOMA
The HYDRUS Microstent - Mechanisms of Action and Clinical Efficacy
SURGICAL RETINA
A More Effective Approach to Internal Limiting Membrane Peeling