## Protocol Section
### Identification Module
**NCT ID:** NCT00501579

**Brief Title:** Study of Difluprednate in the Treatment of Uveitis

#### Organization Study ID Info
**ID:** ST-601A-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Sirion Therapeutics, Inc.
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-08-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-08-27

**Overall Status:** COMPLETED

**Status Verified Date:** 2008-08

#### Study First Post Date
**Date:** 2007-07-16
**Type:** ESTIMATED
**Study First Submit Date:** 2007-07-13
**Study First Submit QC Date:** 2007-07-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sirion Therapeutics, Inc.

#### Responsible Party

**Old Name Title:** Chief Medical Officer

**Old Organization:** Sirion Therapeutics

### Description Module

**Brief Summary:** The purpose of this study is to determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis.

### Conditions Module

**Conditions:**

- Uveitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Difluprednate

**Type:** DRUG

#### Intervention 2

**Name:** Prednisolone Acetate

**Type:** DRUG

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis of endogenous anterior uveitis in at least 1 eye

Exclusion Criteria:

* Presence of intermediate uveitis, posterior uveitis or panuveitis
* Corneal abrasion
* Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease
* Allergy to similar drugs, such as other corticosteroids

**Minimum Age:** 2 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New Albany

**Country:** United States

**Facility:** John-Kenyon American Eye Institute

**State:** Indiana

**Zip:** 47150

#### Overall Officials

**Official 1:**

**Affiliation:** Sirion Therapeutics

**Name:** Roger Vogel, MD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Foster CS, Davanzo R, Flynn TE, McLeod K, Vogel R, Crockett RS. Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis. J Ocul Pharmacol Ther. 2010 Oct;26(5):475-83. doi: 10.1089/jop.2010.0059.

**PMID:** 20809807

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014603

- Term: Uveal Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17353

- Name: Uveitis

- Relevance: HIGH

- As Found: Uveitis

- ID: M17351

- Name: Uveal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5824

- Name: Uveal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014605

- Term: Uveitis

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000018696

- Term: Neuroprotective Agents

- ID: D000020011

- Term: Protective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M14120

- Name: Prednisolone

- Relevance: HIGH

- As Found: Vein

- ID: M11749

- Name: Methylprednisolone

- Relevance: HIGH

- As Found: Smart phone

- ID: M1833

- Name: Methylprednisolone Acetate

- Relevance: HIGH

- As Found: Smart phone

- ID: M11750

- Name: Methylprednisolone Hemisuccinate

- Relevance: HIGH

- As Found: Smart phone

- ID: M229449

- Name: Prednisolone acetate

- Relevance: HIGH

- As Found: Smart phone

- ID: M211887

- Name: Prednisolone hemisuccinate

- Relevance: HIGH

- As Found: Smart phone

- ID: M248881

- Name: Prednisolone phosphate

- Relevance: HIGH

- As Found: Smart phone

- ID: M289314

- Name: Difluprednate

- Relevance: HIGH

- As Found: Skilled

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20773

- Name: Neuroprotective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000011239

- Term: Prednisolone

- ID: D000077555

- Term: Methylprednisolone Acetate

- ID: D000008775

- Term: Methylprednisolone

- ID: D000008776

- Term: Methylprednisolone Hemisuccinate

- ID: C000009935

- Term: Prednisolone acetate

- ID: C000021322

- Term: Prednisolone hemisuccinate

- ID: C000009022

- Term: Prednisolone phosphate

- ID: C000015808

- Term: Difluprednate

### Misc Info Module

- Version Holder: 2024-05-24
