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Study of Difluprednate Ophthalmic Emulsion in Postoperative Inflammation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00406341
First Posted: December 4, 2006
Last Update Posted: December 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sirion Therapeutics, Inc.
  Purpose
The purpose of this phase 3 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

Condition Intervention Phase
Inflammation Drug: Difluprednate Ophthalmic Emulsion Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3 Confimatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treament of Postoperative Inflammation

Resource links provided by NLM:


Further study details as provided by Sirion Therapeutics, Inc.:

Primary Outcome Measures:
  • The changes in anterior chamber cell score at day 14 after start of instillation from the baseline level (differences from the baseline score) were compared between the 2 treatment groups.

Secondary Outcome Measures:
  • The changes in anterior chamber cell score at days 3 and 7 after start of instillation were compared between the 2 treatment groups.
  • The numbers of patients showing an anterior chamber cell score of “0” at days 3, 7 and 14 after start of instillation were compared between the 2 treatment groups.
  • The changes in anterior chamber flare score at days 3, 7 and 14 after start of instillation (difference from the baseline score) were compared between the 2 treatment groups.
  • The changes in the total scores of subjective symptoms and objective signs at days 3, 7 and 14 after start of instillation (difference from the baseline score) were compared between the 2 treatment groups.

Estimated Enrollment: 200
Study Start Date: April 2004
Estimated Study Completion Date: March 2005
Detailed Description:
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with intraocular postoperative inflammation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery at the same time)
  • Patients showing an anterior chamber cell score of not less than “2” at a day after surgery
  • Patients aged 20 years or over, irrespective of genders (it is eligible for enrollment when patients’ age attains the criterion on the day of consent obtainment)

Exclusion Criteria:

  • Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs;
  • Patients who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded)
  • Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs;
  • Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery);
  • Patients who underwent perioperative and/or postoperative intravitreous injection of corticosteroids;
  • Patients who underwent sub-conjunctival injection or sub-Tenon capsule injection of corticosteroids;
  • Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations;
  • Patients who underwent gas tamponade at the surgery;
  • Patients with endogenous uveitis;
  • Patients having corneal epithelial detachment or corneal ulcer in the target eye;
  • Patients who are suspected of having viral, bacterial or mycotic keratoconjunctival disorders in the target or opposite eye;
  • Patients with glaucoma or ocular hypertension, or those with past history of IOP increased due to instillation of corticosteroids, or those whose IOP has been controlled by use of ophthalmic antihypertensive agents;
  • Patients showing IOP not less than 25 mmHg a day after surgery;
  • Patients who have allergy to corticosteroid drugs;
  • Patients who are required to wear contact lens during the study period;
  • Patients who are scheduled to undergo surgery of the opposite eye during the study period;
  • Patients who are pregnant or may be pregnant or lactating;
  • Patients who have participated in other clinical studies within 3 months.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406341


Sponsors and Collaborators
Sirion Therapeutics, Inc.
Investigators
Study Chair: Shigeaki Ohno Department of Ophthalmology and Visual Sciences, Graduate School of Medicine, Hokkaido University
  More Information

ClinicalTrials.gov Identifier: NCT00406341     History of Changes
Other Study ID Numbers: SJE2079/3-03
First Submitted: November 29, 2006
First Posted: December 4, 2006
Last Update Posted: December 4, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Difluprednate
Fluprednisolone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents