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CompletedNCT00407225Updated Dec 6, 2006

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

A Phase 2 interventional study of Difluprednate Ophthalmic Emulsion in Inflammation, sponsored by Sirion Therapeutics, Inc.. Completed. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2006-12-06.

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

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
12 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 postoperative inflammation.

Read the detailed description

The objective is to assess the efficacy and safety of 0.002% and 0.05% difluprednate ophthalmic emulsions in patients with postoperative inflammation after cataract surgery (implantation of intraocular lens). In addition, the evaluation system for a future dose-finding phase III study of difluprednate ophthalmic emulsion will be established.

02

Conditions studied

  • Inflammation

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation 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
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with a mean postoperative (on the day of surgery or the day after surgery) flare intensity of 30 photon counts/msec
  • Male and female patients aged 12 and \<75 years who were able to accurately express their own symptoms
  • Patients providing written informed consent prior to the start of the study
  • Inpatients (patients were allowed to be discharged from the hospital during the study period)

Exclusion criteria

Exclusion Criteria:

  • Patients who did not meet any of the above inclusion criteria
  • Patients receiving systemic administration, or topical application to the head or face (including instillation to the eyes) of any steroid, nonsteroidal anti-inflammatory drug, antiphlogistic enzyme, immunosuppressive drug or colchicine within 1 week prior to the start of the study treatment
  • Patients with glaucoma or ocular hypertension (IOP: 21 mmHg)
  • Patients with corneal abrasion or ulcer
  • Patients with any viral keratoconjunctival disease, tuberculosus eye disease, fungal eye disease or bacterial eye disease

  • Patients with diabetes who met any of the following criteria

    • HbA1C was 9.0% within 1 month prior to obtaining informed consent.
    • Proliferative diabetic retinopathy was present.
    • Rubeosis iridis was present.
  • Patients with allergy to steroids
  • Patients requiring the use of contact lens during the study period
  • Women who were or might be pregnant
  • Patients participating in another clinical study within 6 months prior to the start of the present study
  • Patients sensitive to steroids (patients who previously experienced increased IOP after instillation of a steroid)
  • Patients with a Grade 5 nuclear hardness as diagnosed according to Emery-Little classification
  • Patients with fibrins or posterior rupture at baseline (F0)
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 flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).

  2. The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to

  3. the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each

  4. ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the

  5. between-group difference in the effect of difluprednate became significant.

Secondary outcomes

  1. The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared

  2. with the baseline total score (S0).

  3. As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs

  4. (cells and protein) on Day 1 (S1), that on Day 31 (S3) and that on Day 72 (S7) to the baseline

  5. total score (S0) (S1/S0, S3/S0 and S7/S0, respectively) were determined. Each ratio was

  6. compared between the 0.002% and 0.05% difluprednate groups to identify when the

  7. between-group difference in the effect of difluprednate became significant.

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 Dec 6, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00407225
Lead sponsor
Sirion Therapeutics, Inc.
First posted
Dec 4, 2006
Start date
Dec 1999
Completion
Oct 2000
Last update
Dec 6, 2006

Study contacts

Kanjiro Masuda
study chair · Director, Kanto Rosai Hospital; Director, Japanese Red Cross Medical Center
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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