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Last Updated: November 14, 2019

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CLINICAL TRIALS PROFILE FOR FLUORESCEIN SODIUM

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505(b)(2) Clinical Trials for Fluorescein Sodium

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00610480 Effects of Tear Film Stability After Instillation Of OTC Artificial Drops Completed Investigator initiated study N/A 2007-11-01 The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ and Soothe™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.
OTC NCT00610480 Effects of Tear Film Stability After Instillation Of OTC Artificial Drops Completed University of Texas Southwestern Medical Center N/A 2007-11-01 The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ and Soothe™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fluorescein Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000115 Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema Completed National Eye Institute (NEI) Phase 2 1990-12-01 To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
NCT00001863 Leflunomide to Treat Uveitis Completed National Eye Institute (NEI) Phase 2 1999-03-01 This study will investigate the safety and effectiveness of the drug Leflunomide to treat uveitis-an inflammation of the eye caused by an immune system abnormality. Leflunomide suppresses immune system activity and has been shown to control autoimmune diseases, such as arthritis (joint inflammation), in animals. It has also improved symptoms in patients with rheumatoid arthritis, and the Food and Drug Administration has approved it for treating patients with this disease. Eye and joint inflammation may have similar causes, and medicines for arthritis often help patients with eye inflammation. This study will examine whether Leflunomide can help patients with uveitis. Patients with uveitis who are not responding well to steroid treatment and patients who have side effects from other medicines used to treat uveitis (such as cyclosporine, cyclophosphamide, methotrexate or azathioprine) or have refused treatment because of possible side effects of these medicines may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood test and eye examination. The eye exam includes a check of vision and eye pressure, examination of the back of the eye (retina) with an ophthalmoscope and the front of the eye with a microscope. They will also undergo a procedure called fluorescein angiography to look at the blood vessels of the eye. A dye called sodium fluorescein is injected into the bloodstream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina. Study participants will be divided into two groups. One group will take 100 milligrams of Leflunomide once a day for 3 days and then 20 milligrams once a day for 6 months. The other group will take a placebo-a pill that looks like the Leflunomide pill but does not contain the medicine. All patients in both groups will also take prednisone. Patients will have follow-up examinations at weeks 1, 4, 8, 12, 16, and 24 (6 months) of the study. Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine. Those who do well and want to continue their assigned treatment after 6 months can continue that treatment for another 6 months and will have follow-up exams at months 9 and 12.
NCT00008515 Fluocinolone Implant to Treat Macular Degeneration Completed National Eye Institute (NEI) Phase 1 2001-01-01 This study will test the safety and effectiveness of a fluocinolone implant to treat age-related macular degeneration. This eye disease can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. It is the leading cause of vision loss in people over age 60. The fluocinolone implant is a tiny plastic rod with a pellet of the steroid fluocinolone on the end. The pellet slowly dissolves and releases the medication into the fluid in the eye. Vision loss in macular degeneration is caused by the formation of new blood vessels in the choroid-a thin, pigmented vascular layer of the eye behind the retina. These abnormal vessels leak blood under the macula, the part of the retina that determines central vision. Tissue studies show evidence of inflammation in the retinas of patients. This study will test whether the slow release of the steroid fluocinolone directly into the affected part of the eye can prevent or slow further vision loss. Preliminary animal and human studies with fluocinolone implants have shown some benefit in reducing blood vessel growth and improving or stabilizing vision. Patients 50 years of age and older with age-related macular degeneration may be eligible for this study. Study patients will be randomly assigned to one of two treatment groups. One will receive a 0.5-mg dose implant; the other will receive a 2-mg dose implant. Theoretically, the implants can release the medicine for 2 to 3 years. Participants will have a medical history, physical examination and complete eye examination. The latter will include a vision test, eye pressure measurement, examination of the pupils, lens, retina, and eye movements. Photographs of the eye will be taken with a special camera. Patients will also undergo fluorescein angiography, a test that takes pictures of the retina using a yellow dye called sodium fluorescein. The dye is injected into the blood stream through a vein. After it reaches the blood vessels of the eye, photographs are taken of the retina. When the above tests are completed, patients will be scheduled for surgery to place the implant. The procedure will be done under either local or general anesthesia. Follow-up visits will be scheduled 1, 2, 4, and 6 weeks after surgery, then at 3 and 6 months after surgery, and then every 6 months until the implant is depleted of medicine or is removed. Several of the exams described above will be repeated during the follow-up period to evaluate the treatment and side effects, if any.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fluorescein Sodium

Condition Name

Condition Name for Fluorescein Sodium
Intervention Trials
Macular Degeneration 3
Stage IIIC Skin Melanoma 2
Stage IIC Skin Melanoma 2
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Condition MeSH

Condition MeSH for Fluorescein Sodium
Intervention Trials
Keratoconjunctivitis Sicca 5
Dry Eye Syndromes 5
Macular Degeneration 4
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Clinical Trial Locations for Fluorescein Sodium

Trials by Country

Trials by Country for Fluorescein Sodium
Location Trials
United States 24
China 3
Canada 3
Japan 1
India 1
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Trials by US State

Trials by US State for Fluorescein Sodium
Location Trials
New York 6
Texas 4
Massachusetts 3
Florida 3
Maryland 2
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Clinical Trial Progress for Fluorescein Sodium

Clinical Trial Phase

Clinical Trial Phase for Fluorescein Sodium
Clinical Trial Phase Trials
Phase 4 7
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Fluorescein Sodium
Clinical Trial Phase Trials
Completed 16
Recruiting 11
Not yet recruiting 5
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Clinical Trial Sponsors for Fluorescein Sodium

Sponsor Name

Sponsor Name for Fluorescein Sodium
Sponsor Trials
Roswell Park Cancer Institute 3
University of Texas Southwestern Medical Center 3
National Cancer Institute (NCI) 3
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Sponsor Type

Sponsor Type for Fluorescein Sodium
Sponsor Trials
Other 43
NIH 8
Industry 5
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