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Do you suffer from Blepharitis?

InSite Vision, Inc. is conducting a “Blepharitis” clinical research study to evaluate the clinical effectiveness and safety of an investigational* study drug.

What is Blepharitis?

Blepharitis is inflammation that affects the eyelids. It generally involves the part of the eyelid where the eyelashes grow. Blepharitis occurs when tiny oil glands located near the base of the eyelashes are not working properly. This leads to inflamed, irritated and itchy eyelids.

To find out if you may qualify to participate in our Blepharitis clinical research study,

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Signs & Symptoms

Watery eyes
Red eyes
A gritty, burning sensation in the eye
Eyelids that appear greasy
Itchy eyelids
Red, swollen eyelids
Flaking of skin around the eyes
Crusted eyelashes upon awakening
Sensitivity to light

Treatment options can include:

Cleaning the affected area regularly
Antibiotics
Steroid eyedrops or ointments
Artificial tears

*An investigational study drug is a drug that is being tested in a clinical research study, but not yet approved by the Food and Drug Administration to be legally marketed and sold.

What is a clinical research study?

A clinical research study is a research study in human volunteers to answer specific health questions. Through clinical research studies, doctors find new and better ways to prevent, detect, diagnose, control, and treat illnesses.

What does informed consent mean?

Informed consent is a process in which an individual learns key facts about a clinical trial, including possible alternative treatments, potential risks and benefits, before deciding whether or not to participate in a research study.

What is an institutional review board (IRB) or independent ethics committee (IEC)?

An institutional review board (IRB), also known as an independent ethics committee (IEC), is a committee that has been formally designated to approve, monitor, and review clinical research involving humans.

What is IRB / IEC’s role?

IRB/IEC’s role is to protect the rights, safety and well-being of humans involved in a clinical research study by reviewing all aspects of the study and approving clinical research studies startup. Before a site is allowed to start enrolling patients in a clinical research study, the IRB/IEC must review all study-related materials in an initial review. The IRB/IEC also performs periodic reviews (called continuing reviews) throughout the clinical research study’s duration.

The risks or discomforts of participating in this clinical research study are that your Blepharitis condition may not improve, could remain the same, or could even worsen if you take part in this clinical research study.
In a Clinical Study of ISV-502 conducted by InSite Vision, the most frequently reported adverse events were eye irritation, reported by 9.3% (13/140) of the subjects, eye site reaction, 3.6% (5/140), and eye pain, reported by 3.6% (5/140) of the subjects.

Costs: You do not have to pay for the investigational study drug, study visits, and tests that have to be done for the clinical research study.

Compensation for Research-Related Injury: If you are injured as a result of the investigational study drug or study procedures performed during your participation in this clinical research study you should seek medical attention at the medical provider of your choice. InSite Vision, Inc. will cover the medical expenses necessary to treat the injury only to the extent that such costs are not covered by your health insurance policy.