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Completed

NCT Number: NCT00406887

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

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

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Key information

Conditions

Anterior Uveitis Eye Diseases Panuveitis Uveal Diseases Uveitis Uveitis, Anterior

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with endogenous anterior uveitis or panuveitis
  • Patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3)
  • Patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms
  • Patients provided written informed consent prior to initiation of the study

Exclusion criteria

  • Patients who did not meet all of the above inclusion criteria
  • Patients received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product
  • Patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (Solution formulation: within the past 1 week, depot: within the past 2 weeks)
  • Patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product
  • Patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product
  • Patients with glaucoma or ocular hypertension
  • Patients with corneal abrasion or ulcer
  • Patients with any confirmed or suspected viral, bacterial or fungal keratoconjunctival disease
  • Patients with allergy to similar drugs such as other corticosteroids
  • Patients requiring use of contact lens during the study period
  • Women who are or might be pregnant, or lactating women
  • Patients participating in another clinical study within the past 3 months before initiation of the present study

Treatment and study plan

Difluprednate Ophthalmic Emulsion

Drug

Primary outcomes

  1. The difference from the baseline in anterior chamber cell score on Day 14

  2. was compared between the two groups.

Secondary outcomes

  1. The differences from the baseline in anterior chamber cell score on Days 3 and 7

  2. were compared between the two groups.

  3. The numbers of patients with an anterior chamber cell score of 0 on Days 7 and

  4. 14 were compared between the two groups.

  5. The differences from the baseline in total sign and symptom scores on Days 3, 7

  6. and 14 were compared between the two groups.

  7. The numbers of patients with an anterior chamber cell score of 1 or less on Days

  8. 3, 7 and 14 were compared between the two groups.

Sponsors and collaborators

Lead sponsor

Sirion Therapeutics, Inc.

Industry

Registry information

Official study title

Phase 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).

Important dates

Study start
2002
Study completion
2003
First posted
Dec 4, 2006
Registry last updated
Dec 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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