A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects with Active Non-infectious Anterior Uveitis including Subjects with Uveitic Glaucoma
The purpose of this study is to investigate the effectiveness and safety of the investigational product, TRS01, in treating the signs and symptoms of anterior uveitis in participants with active, non-infectious anterior uveitis including participants with uveitic glaucoma. TRS01 is an investigational drug, which means it has not been approved by the United States Food and Drug Administration (FDA) for use except in research studies.
The effects of TRS01 eye drops will be compared to an FDA approved corticosteroid eye drop.
Doctors commonly use anti-inflammatory drugs called corticosteroids delivered as eye drops to reduce the inflammation and treat anterior non-infectious uveitis. However, continued use of corticosteroids to help with inflammation can have side effects, like increased pressure inside the eye (intraocular pressure) and cataract. TRS01 is different from existing anti-inflammatory medications because it is not a corticosteroid and could help with inflammation without the same side effects.
Main Procedures Involved: The following tests and procedures will be performed to ensure that you are eligible and it is safe for you to be part of this study and later to measure the safety and effect of the study product. Many of the tests and procedures listed below (for example, the visual acuity assessment, slit lamp biomicroscopy, intraocular pressure measurement, dilated ophthalmoscopy exam, and blood tests) are standard care for patients with anterior uveitis or uveitic glaucoma: ? Medical History – Review of your eye health, medical history, and surgical history ? Participant-Rated Ocular Pain Assessment – You will be asked to rate your eye pain, if any, at each study visit. ? Participant-Rated Ocular Photophobia Assessment – You will be asked to rate your sensitivity to light, if any, at each study visit ? Urine Pregnancy Test (if applicable) – If you are a woman who is able to become pregnant (you are neither post-menopausal for 1 year nor surgically sterile), your urine will be tested for pregnancy. ? Visual Acuity Assessment – The study doctor will ask you to read from an eye chart to determine how well you can see. ? Slit Lamp Biomicroscopy – The study doctor will shine a light into your eyes and look at your eyes and eyelids with a microscope to assess the health of the surface of your eyes, eye lashes, eyelids, lens, etc. ? Intraocular Pressure Measurement – The study doctor will measure the fluid pressure inside the eye using an instrument known as a tonometer. To measure the pressure in your eyes, drops will be placed in your eyes which will numb them for several minutes. Then the tonometer (pressure measurement device) is placed against the surface of the eye. You should not feel this on your eye. ? Dilated Ophthalmoscopy – The study doctor will be looking at the back of your eye by shining a light in your eye and examining it with the help of a magnifying lens. To conduct this exam, the study doctor will put special dilating drops in your eyes to dilate your pupils (make them open up), and then the exam will be performed once your eyes have fully dilated. If you do not feel safe to drive after your pupils have been dilated you may need to arrange for someone to pick you up. ? Blood Tests (if applicable) – Based on your medical history, your study doctor may recommend additional blood tests (about 1 tablespoon of blood) be conducted at Visit 1 to determine the cause of your uveitis.
Duration of Participation: Approximately 6 weeks. There is a 28-day treatment period and 14-day follow-up period.
Child to Adult
Alan Palestine, MD
Protocol Number: 21-4454
More information available at ClinicalTrials.gov: NCT05042609
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