Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 2:00 PM
Study NCT ID:
NCT01120132
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 716}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-08', 'studyFirstSubmitDate': '2010-04-29', 'studyFirstSubmitQcDate': '2010-05-07', 'lastUpdatePostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diary assessment of signs and symptoms of ocular allergy', 'timeFrame': 'During the 28 days of treatment', 'description': 'Patient-reported ocular itching and redness'}], 'secondaryOutcomes': [{'measure': 'Diary and office assessments of various ocular and nasal allergy signs and symptoms', 'timeFrame': 'During 28 days of treatment', 'description': 'Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching\n\nInvestigator assessments of ocular redness and chemosis'}, {'measure': 'Safety', 'timeFrame': 'During the 28 days of treatment', 'description': 'Ocular tolerance and adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of ocular allergies and a positive skin test reaction to perennial allergens within the past 24 months and a history of chronic eye irritation\n* visual acuity score ≥ 0.60 (EDTS)\n* negative urine pregnancy test for female patients, and use of adequate birth control throughout the study period.\n\nExclusion Criteria:\n\n* active ocular infection; preauricular lymphadenopathy or ocular condition that could affect study; glaucoma or abnormal intraocular pressure; ocular surgery within past 3 months; history of asthma, pregnancy or nursing\n* contraindications or known allergies to the study drug(s)'}, 'identificationModule': {'nctId': 'NCT01120132', 'briefTitle': 'Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fovea Pharmaceuticals SA'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Administration of FOV1101-00 (Cyclosporine Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Mild Ongoing Ocular Allergic Inflammation', 'orgStudyIdInfo': {'id': 'FOV1101/CLIN202'}, 'secondaryIdInfos': [{'id': '10-003-03', 'type': 'OTHER', 'domain': 'ORA Inc'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclosporine low dose , Prednisolone Acetate', 'description': 'Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate', 'interventionNames': ['Drug: CsA low dose', 'Drug: PA']}, {'type': 'EXPERIMENTAL', 'label': 'Cyclosporine high dose, Prednisolone Acetate', 'description': 'Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate', 'interventionNames': ['Drug: CsA high dose', 'Drug: PA']}, {'type': 'EXPERIMENTAL', 'label': 'Cyclosporine high dose', 'description': 'Administration of a solution of Cyclosporine (high dose) and Placebo', 'interventionNames': ['Drug: CsA high dose', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cyclosporine low dose', 'description': 'Administration of a solution of Cyclosporine (low dose) and Placebo', 'interventionNames': ['Drug: CsA low dose', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisolone Acetate', 'description': 'Administration of a suspension of Prednisolone Acetate and Placebo', 'interventionNames': ['Drug: PA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administration of Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CsA high dose', 'type': 'DRUG', 'description': 'Solution of Cyclosporine (high dose) administered during 28 days', 'armGroupLabels': ['Cyclosporine high dose', 'Cyclosporine high dose, Prednisolone Acetate']}, {'name': 'CsA low dose', 'type': 'DRUG', 'description': 'Solution of Cyclosporine (low dose) administered during 28 days', 'armGroupLabels': ['Cyclosporine low dose', 'Cyclosporine low dose , Prednisolone Acetate']}, {'name': 'PA', 'type': 'DRUG', 'description': 'Suspension of Prednisolone Acetate administered during 28 days', 'armGroupLabels': ['Cyclosporine high dose, Prednisolone Acetate', 'Cyclosporine low dose , Prednisolone Acetate', 'Prednisolone Acetate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo solution administered during 28 days', 'armGroupLabels': ['Cyclosporine high dose', 'Cyclosporine low dose', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'ORA', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'overallOfficials': [{'name': 'Marie-Louise Jacques, MD MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'Fovea Pharmaceuticals SA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fovea Pharmaceuticals SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}