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Study of Difluprednate Ophthalmic Emulsion in Postoperative Inflammation

2010-07-15 17:00:00 | BioPortfolio

Summary

The purpose of this phase 3 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

Description

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with intraocular postoperative inflammation.

Study Design

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

Conditions

Inflammation

Intervention

Difluprednate Ophthalmic Emulsion

Status

Completed

Source

Sirion Therapeutics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

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Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.

Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery

The purpose of this study is to compare the safety and efficacy of difluprednate and prednisolone acetate for the treatment of inflammation following cataract surgery in a pediatric popula...

Evaluation of Efficacy and Safety of Difluprednate Ophthalmic Solution

The study will be conducted to evaluate the efficacy and safety of topical administration of difluprednate ophthalmic solution 0.04% compared with placebo post surgery.

Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002a)

The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.

PubMed Articles [4394 Associated PubMed Articles listed on BioPortfolio]

Application of Ultra-Centrifugation and Bench-TopF NMR for Measuring Drug Phase Partitioning for the Ophthalmic Oil-in-Water Emulsion Products.

Generic drug products are expected to have the same active pharmaceutical ingredient (API) (Q1) with the same content (Q2) and microstructure arrangement (Q3) as the innovator product. In complex oil-...

Asymmetric Flow Field Flow Fractionation for the Characterization of Globule Size Distribution in Complex Formulations: A Cyclosporine Ophthalmic Emulsion Case.

Commonly used characterization techniques such as cryogenic-transmission electron microscopy (cryo-TEM) and batch-mode dynamic light scattering (DLS) are either time consuming or unable to offer high ...

Incorporation of water-in-oil-in-water (W1/O/W2) double emulsion in a set-type yogurt model.

The effect of W1/O/W2 emulsion incorporation in set-type yogurt on the acidification process, physicochemical properties, bacterial growth kinetics and structural characteristics was investigated. The...

Discrepancies between vascular and systemic inflammation in large vessel vasculitis: an important problem revisited.

A lack of absolute correlation between systemic inflammation parameters and ongoing vascular disease activity is an important problem in some patients with large vessel vasculitis, especially Takayasu...

Effect of asymmetric wettability in nanofiber membrane by electrospinning technique on separation of oil/water emulsion.

Oil/water separation is an important issue in the environmental field because of increasing worldwide oil pollution. In particular, emulsion under 20 μm in size causes a serious problem in water tr...

Medical and Biotech [MESH] Definitions

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.

An emulsion of solid color which when spread over a surface leaves a thin decorative and or protective coating.

Inflammation of the PERIAPICAL TISSUE. It includes general, unspecified, or acute nonsuppurative inflammation. Chronic nonsuppurative inflammation is PERIAPICAL GRANULOMA. Suppurative inflammation is PERIAPICAL ABSCESS.

A film base coated with an emulsion designed for use with x-rays.

An experimental animal model for central nervous system demyelinating disease. Inoculation with a white matter emulsion combined with FREUND'S ADJUVANT, myelin basic protein, or purified central myelin triggers a T cell-mediated immune response directed towards central myelin. The pathologic features are similar to MULTIPLE SCLEROSIS, including perivascular and periventricular foci of inflammation and demyelination. Subpial demyelination underlying meningeal infiltrations also occurs, which is also a feature of ENCEPHALOMYELITIS, ACUTE DISSEMINATED. Passive immunization with T-cells from an afflicted animal to a normal animal also induces this condition. (From Immunol Res 1998;17(1-2):217-27; Raine CS, Textbook of Neuropathology, 2nd ed, p604-5)

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