About Clinical Trials

Clinical trials make new treatments possible by ensuring the safety and efficacy of promising new drugs and devices.

What is a clinical trial?

Clinical trials are research studies that assess the effectiveness and safety of a medication or device. Clinical trials are usually put into place to determine if a new therapy for a specific disease is more effective than the current U.S. Drug and Food Administration (FDA) approved treatment. Sometimes, clinical trials are utilized to determine if an FDA approved treatment can be effective and safe in an entirely different condition.

Efficacy and safety studies for a clinical trial are always tested on animal subjects prior to being approved by the FDA to begin studies on humans.

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Here’s what to expect when you enroll in a clinical trial

Pre-screening

Prior to participation in a clinical trial, our recruitment experts will guide you through the pre-screening process. This usually consists of questions regarding your health and medication history to determine if you are eligible for the clinical trial. Our recruitment team will determine if you qualify based on inclusion and exclusion criteria.

Inclusion criteria: factors that qualify a patient for a clinical trial
Exclusion criteria: factors that disqualify a patient for a clinical trial

In some countries, compensation is available for participation and these details will be shared with you before the study begins. 

Informed Consent

Once you qualify for a study, you will go through an informed consent process. An informed consent is designed to provide important information about a clinical trial, including risks and benefits. We encourage you to ask questions if you don’t understand something outlined in the informed consent. 

Screening Tests

At your initial visit to the clinical study site, you will undergo screening tests, which are all outlined in the informed consent form. These tests may be similar to tests performed at a regular eye exam. Your health will be continually monitored throughout the clinical trial process. It’s important to remember that you may discontinue participation in a clinical study at any point of your journey.

After the clinical trial is complete, results may be published in peer-reviewed journals, which means the entries are examined by experts in the field. If the therapy is proven to be safe and effective, it may be approved by the FDA and may become a standard treatment used in practice.

Download our “What to Expect” guide that outlines the clinical trial journey.

Download our Guide

Phases of a Clinical Trial

Below are the phases of a clinical trial.
It’s important to note that participants’ health and well-being is closely monitored through their entire clinical study journey in every phase.

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Phase 1

  • Assesses the safety of a new therapy in a small number of participants
  • Participants are divided into cohorts, where doctors closely monitor the side effects of the therapy and determine if it’s safe to administer to a second cohort with a higher dose of the therapy
  • This process is continued until an optimal dose of the therapy is established
  • Participants are closely monitored with health examinations and lab testing

Phase 2

  • Assesses the effectiveness of the therapy being studied

Phase 3

  • Assesses if the therapy being studied is more effective than the current standard treatment
  • Participants are divided into a treatment group, where the investigative therapy is administered, and a control group, where the current standard therapy or a placebo (no treatment) is administered

Phase 4

  • After a therapy is FDA-approved, long-term side effects are monitored

Your rights, protection, and safety through the clinical trial journey

Institutional Review Board (IRB)

In the USA, most clinical trials are approved by an Institutional Review Board (IRB), which ensures the benefits of an investigational therapy outweigh potential risks. The IRB consists of doctors, scientists, and members of your community to ensure that a clinical trial is created ethically and with the safety and well-being of participants in mind.

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Informed Consent

The informed consent is provided to participants prior to beginning the clinical trial. An informed consent includes the therapy being investigated, the potential risks, alternative standard treatments for the indication in question, length of the clinical trial, expectations from the participants, and much more. The informed consent is meant to provide all information needed for you to make the best decision for you. We welcome any and all questions regarding the informed consent and clinical trial itself. It’s so important that patients know they can unenroll from a clinical trial at any point for any reason.

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Information Protection

Your personal and medical information is entirely protected before, throughout, and after the clinical trial process through the HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule. You will also be informed of who has access to your personal information.

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Why does clinical research matter?

Clinical research is incredibly important as being involved in a clinical trial can shape the way diseases are treated in the future and can positively affect others who are suffering from the same condition. Clinical studies are essential for any new medications or devices or new indications for these therapies to be FDA-approved and used extensively by patients.

Advancements in therapies for disease through clinical trials can improve health, reduce pain and other symptoms from disease, and can increase life expectancy and quality of life.

Benefits of Getting Involved in Clinical Research

There are multiple benefits to participating in a clinical study to not only for yourself, but for others with the same condition. Some of these benefits include:

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Hope for symptom relief and care of your ocular condition

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Contribution to the advancement of ophthalmic clinical research

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May provide patients with better treatments for similar ocular conditions

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Frequent health checkups with medical providers through the clinical trial process

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Exposure to further education and resources on your condition

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Compensation for your time (in some countries)

Risk of Getting Involved in Clinical Research

Although there are many benefits to participating in a clinical research study, there are some risks to consider. All potential risks are outlined in the informed consent form. They are as follows:

  1. Significant or uncomfortable side effects of treatment
  2. Treatment may not relieve symptoms or improve your health
  3. You may not be placed in the “treatment group”, meaning you receive a placebo or current standard treatment
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Learn more about joining a study

Learn more about becoming one of our patients and the benefits to be had.