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Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

2014-08-27 03:16:21 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Keratoconjunctivitis Sicca

Intervention

rebamipide 2% ophthalmic suspension, placebo eye drops

Location

Cornea Consultants of Arizona
Phoenix
Arizona
United States
85032

Status

Recruiting

Source

Acucela Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:21-0400

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Study of Rebamipide Eye Drops to Treat Dry Eye

The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivi...

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PubMed Articles [1957 Associated PubMed Articles listed on BioPortfolio]

The Role of 2% Rebamipide Eye Drops Related to Conjunctival Differentiation in Superoxide Dismutase-1 (Sod1) Knockout Mice.

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Medical and Biotech [MESH] Definitions

Chronic inflammatory and autoimmune disease in which the salivary and lacrimal glands undergo progressive destruction by lymphocytes and plasma cells resulting in decreased production of saliva and tears. The primary form, often called sicca syndrome, involves both KERATOCONJUNCTIVITIS SICCA and XEROSTOMIA. The secondary form includes, in addition, the presence of a connective tissue disease, usually rheumatoid arthritis.

Drying and inflammation of the conjunctiva as a result of insufficient lacrimal secretion. When found in association with XEROSTOMIA and polyarthritis, it is called SJOGREN'S SYNDROME.

The administration of therapeutic agents drop by drop, as eye drops, ear drops, or nose drops. It is also administered into a body space or cavity through a catheter. It differs from irrigation in that the irrigate is removed within minutes, but the instillate is left in place.

Ophthalmic solutions that include LUBRICANTS and WETTING AGENTS such as POLYETHYLENE GLYCOL; HYPROMELLOSE; GLYCEROL; PROPYLENE GLYCOL. They are used to treat conditions caused by deficient tear production such as DRY EYE SYNDROME.

A species of gram-negative, aerobic bacteria that is most frequently isolated from bovine eyes in cases of infectious keratoconjunctivitis (KERATOCONJUNCTIVITIS, INFECTIOUS), but also occurs in unaffected eyes and the nasal cavity of cattle.

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