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Completed

NCT Number: NCT00407056

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.

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Key information

Conditions

Uveitis Eye Diseases Panuveitis Uveal Diseases

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 in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a diagnosis of endogenous anterior uveitis or panuveitis
  • Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)
  • Patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day)
  • Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms
  • Patients giving written informed consent prior to initiation of the study

Exclusion criteria

  • Patients who did not meet all of the above inclusion criteria
  • Patients initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug
  • Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product)
  • Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
  • Patients with glaucoma or ocular hypertension
  • Patients with corneal erosion or corneal ulcer
  • Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection
  • Patients with allergy to similar drugs of difluprednate
  • Patients requiring use of contact lens during the study period
  • Women who were or might be pregnant, or lactating women
  • Patients participating in another clinical study within 3 months before initiation of the present study

Treatment and study plan

Difluprednate Ophthalmic Emulsion

Drug

Primary outcomes

  1. The anterior chamber cell score was compared between baseline and Day 14.

Secondary outcomes

  1. The anterior chamber cell score was compared between baseline and Days 3 and 7.

  2. The total symptom score (sum of eye pain, photophobia, blurred

  3. vision, foreign body sensation and lacrimation scores) and total

  4. sign score (sum of anterior chamber cell, anterior chamber flare,

  5. ciliary hyperemia, keratic precipitate and synechia of iris and

  6. posterior scores) were compared between baseline and Days 3, 7

  7. and 14.

Sponsors and collaborators

Lead sponsor

Sirion Therapeutics, Inc.

Industry

Registry information

Official study title

Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe 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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