Reviewed by Michael Gill, B. Sc.
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What Are Restasis Clinical Trials?

Restasis is the brand name for the eye drops that are also called cyclosporine, and it is used for the treatment of dry eye disease (DED). Restasis clinical trials are important because prescription drugs for eye disorders cost Americans as much as 11 billion dollars annually and dry eye disease is among the most common cause of ocular treatment in the United States.

Dry eye disease occurs when the surface of the eye loses its tear film and inflammation occurs that results in the disease known as DED or keratoconjunctivitis sicca. In addition to being unable to produce tears, the patient will suffer from some visual changes or disturbances. Researchers have been performing Restasis clinical trials since the late 1990s in order to find the most efficient vehicle that will help in tear production and reduce the visual disturbances that are the result of dry eye disease.

Why Is Restasis Being Studied In Clinical Trials?

Clinical research from Restasis clinical trials determines the efficiency of Restasis as a vehicle for increasing tear production in patients with dry eye disease, and by how much. It is often used alongside other anti-inflammatory vehicles in order to determine its efficacy. As a result of the initial Restasis clinical trials that began in the late 1990s, Restasis was approved by the Federal Drug Administration (FDA) in 2003 to treat dry eye disease. By 2022, the FDA approved the first generic form of Restasis for the public, as a result of the success of Restasis clinical trials using various compounds of the same ocular emulsion or eye drops.

How Does Restasis Treatment Work?

Restasis is a prescription eye drop that is given to patients sixteen of age or older when it is indicated that they have a chronic dry eye, likely accompanied by some visual disturbances. It is a white powder that is developed with ophthalmic emulsion products to create an eye drop that can treat chronic inflamed dry eyes.

Restasis does not simply moisten the eye in order to reduce inflammation, but it also helps in the assistance of natural tear production.

What Are Some of the Breakthrough Clinical Trials Involving Restasis?

Restasis is a medication that has been undergoing many clinical trials since the late 1990s, which have continued after it received FDA approval in 2003.

2000: Researchers conducted Restasis clinical trials in two centers where two different formulations of Restasis were used in order to determine their safety and efficacy. The formulations were CsA 0.05 percent and CsA 0.1 percent and the clinical trials were conducted in two different centers across a six-month period in 877 patients with dry eye disease. Here, there were 292 patients in each group, including controls. Results indicated greater success with CsA 0.1 percent formulation over the CsA 0.05 percent formulation although both were considered effective in treating dry eye disease.

2012: In this Restasis clinical trial for the journal of Clinical Ophthalmology, researchers examined the effects of cyclosporine after Restasis had been previously discontinued by some patients. In the study with 35 patients, 80 percent reported improvement with their dry eye disease after continuing with a second trial of cyclosporine.

Who Are The Key Opinion Leaders On Restasis Clinical Trial Research?

Dr. M. Vanathi MD

Dr. M. Vanathi is a professor of ophthalmology in cornea, cataract & refractive surgery services at the All India Institute of Medical Sciences in India. She has performed a great number of surgeries in ophthalmology and published numerous studies on the efficacy of Restasis in patients with dry eye disease.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: November 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

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