Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:59 PM
Study NCT ID:
NCT00407056
Status:
COMPLETED
Last Update Posted:
2006-12-04
First Post:
2006-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D015864', 'term': 'Panuveitis'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2003-06'}, 'lastUpdateSubmitDate': '2006-11-29', 'studyFirstSubmitDate': '2006-11-29', 'studyFirstSubmitQcDate': '2006-11-29', 'lastUpdatePostDateStruct': {'date': '2006-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The anterior chamber cell score was compared between baseline and Day 14.'}], 'secondaryOutcomes': [{'measure': 'The anterior chamber cell score was compared between baseline and Days 3 and 7.'}, {'measure': 'The total symptom score (sum of eye pain, photophobia, blurred'}, {'measure': 'vision, foreign body sensation and lacrimation scores) and total'}, {'measure': 'sign score (sum of anterior chamber cell, anterior chamber flare,'}, {'measure': 'ciliary hyperemia, keratic precipitate and synechia of iris and'}, {'measure': 'posterior scores) were compared between baseline and Days 3, 7'}, {'measure': 'and 14.'}]}, 'conditionsModule': {'conditions': ['Uveitis', 'Panuveitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of endogenous anterior uveitis or panuveitis\n* Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)\n* 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)\n* Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms\n* Patients giving written informed consent prior to initiation of the study\n\nExclusion Criteria:\n\n* Patients who did not meet all of the above inclusion criteria\n* 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\n* 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)\n* Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug\n* Patients with glaucoma or ocular hypertension\n* Patients with corneal erosion or corneal ulcer\n* Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection\n* Patients with allergy to similar drugs of difluprednate\n* Patients requiring use of contact lens during the study period\n* Women who were or might be pregnant, or lactating women\n* Patients participating in another clinical study within 3 months before initiation of the present study'}, 'identificationModule': {'nctId': 'NCT00407056', 'briefTitle': 'Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sirion Therapeutics, Inc.'}, 'officialTitle': 'Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).', 'orgStudyIdInfo': {'id': 'SJE2079/3-02-PC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Difluprednate Ophthalmic Emulsion', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shigeaki Ono', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sirion Therapeutics, Inc.', 'class': 'INDUSTRY'}}}}