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CompletedNCT00405496Updated Nov 30, 2006

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

A Phase 2 interventional study of Difluprednate Ophthalmic Emulsion in Anterior Uveitis, sponsored by Sirion Therapeutics, Inc.. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2006-11-30.

Sponsored by Sirion Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

The primary objective was to investigate the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for treatment of this disease in the early phase of development, in comparison with Rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid ophthalmic solution.

The secondary objective was to establish the evaluation system for a dose-finding study.

02

Conditions studied

  • Anterior Uveitis
03

In context

Uveitis

335 studies on the registry are indexed under Uveitis; 37 are open to participants now.

This study's enrollment of 24 is below the median of 30 across 208 interventional studies indexed under Uveitis.

Browse Uveitis studies →

Lead sponsor

Sirion Therapeutics, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with endogenous anterior uveitis (including panuveitis)
  • Patients with 20 or more anterior chamber cell within one field of the aqueous humor (Grade 3 or higher in clinical signs and grading) as measured with a slitlamp microscope
  • Patients aged ≥20 years and \<75 years who could clearly express their subjective symptoms (Patients aged 20 years at giving informed consent were included in the study.)
  • Patients giving written informed consent prior to initiation of the study

Exclusion criteria

Exclusion Criteria:

  • Patients who did not meet all of the above inclusion criteria
  • Patients receiving systemic administration or topical administration to the head or face including instillation of corticosteroid, nonsteroidal anti-inflammatory drugs, antiphlogistic enzymes, immunosuppressive drugs or colchicines within 1 week before the initial instillation of the study drug
  • Patients with glaucoma or ocular hypertension (IOP ≥21 mmHg)
  • Patients with corneal erosion or corneal ulcer
  • Patients with viral keratoconjunctival diseases, tuberculos eye diseases, fungal eye diseases or bacterial eye diseases
  • Patients with diabetes mellitus
  • Patients with allergy to corticosteroids
  • Patients requiring use of contact lens during the study period
  • Women who were or might be pregnant
  • Patients participating in other clinical studies within 6 months before initiation of the present study
  • Patients with sensitivity to steroids(Patients who previously exhibited increased IOP after instillation of a steroid ophthalmic solution)
  • Patients with fibrins to such an extent that might affect measurement of flare
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
24 participants

Interventions

  • DrugDifluprednate Ophthalmic Emulsion
06

What researchers measure

Primary outcomes

  1. The anterior chamber cell score was compared between baseline and after completion of the

  2. study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the

  3. reduction of anterior chamber cell.

Secondary outcomes

  1. The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value

  2. (baseline/after completion of the study treatment ratio), as measured with a laser flare cell

  3. meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical

  4. signs and symptoms after completion of the study treatment (142 days) from baseline.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00405496
Lead sponsor
Sirion Therapeutics, Inc.
First posted
Nov 30, 2006
Start date
Mar 2000
Completion
Apr 2001
Last update
Nov 30, 2006

Study contacts

Kanjiro Masudo
study chair · Director, Kanto Rosai Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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