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Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome

2014-07-23 21:55:15 | BioPortfolio

Summary

A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Keratoconjunctivitis Sicca

Intervention

Ophthalmic Emulsion

Location

Eyecare of La Jolla
La Jolla
California
United States
92037

Status

Completed

Source

Allergan

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:55:15-0400

Clinical Trials [480 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca

This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye s...

Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease

This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments complete...

Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicc...

A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)

This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.

Kinetic Oscillation Stimulation (KOS) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye Syndrome)

The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation (KOS) in the nasal cavity in patients with Keratoconjunctivitis sicca can relieve these symtoms.

PubMed Articles [625 Associated PubMed Articles listed on BioPortfolio]

Efficacy and Safety of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, for the Treatment of Keratoconjunctivitis Sicca: Pooled Analysis of a Phase 2b/3 and Phase 3 Study.

OTX-101 (CEQUA™) is approved in the United States for treatment of keratoconjunctivitis sicca (KCS). This pooled analysis of 2 studies (phase 2b/3 and phase 3) evaluates the efficacy and safety of O...

Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Corneal Staining in Patients With Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies.

Keratoconjunctivitis sicca affects 5% to 33% of the population and is often accompanied by symptoms such as burning and dryness. This pooled analysis evaluated total and central corneal fluorescein st...

Reduction in the inflammatory markers CD4, IL-1, IL-6 and TNFα in dogs with keratoconjunctivitis sicca treated topically with mesenchymal stem cells.

Keratoconjunctivitis sicca (KCS) is of predominantly immune-mediated origin. Dogs are an excellent model for understanding this disease, as the origin of KCS in dogs is like that in humans. The object...

Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Conjunctival Staining in Patients with Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and 3 Clinical Trials.

Keratoconjunctivitis sicca (KCS), a multifactorial disease, is the most common ocular condition for patients seeking medical treatment and is characterized by ocular burning, stinging, and dryness. Th...

Efficacy and safety of 0.05% cyclosporine ophthalmic emulsion in treatment of Chinese patients with moderate to severe dry eye disease: A 12-week, multicenter, randomized, double-masked, placebo-controlled phase III clinical study.

Dry eye disease (DED) is a chronic ocular surface disease that affects hundreds of millions of people worldwide. Although 0.05% cyclosporine ophthalmic emulsion (CsA OE) has long been prescribed in th...

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.

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.

A sensory branch of the trigeminal (5th cranial) nerve. The ophthalmic nerve carries general afferents from the superficial division of the face including the eyeball, conjunctiva, upper eyelid, upper nose, nasal mucosa, and scalp.

A species of gram-negative, aerobic BACTERIA found in the human NASOPHARYNX; SALIVA; and SPUTUM.

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