Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01275105
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
2011-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'dispFirstSubmitDate': '2012-02-24', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-02', 'studyFirstSubmitDate': '2011-01-10', 'dispFirstSubmitQcDate': '2012-03-01', 'studyFirstSubmitQcDate': '2011-01-11', 'dispFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conjunctival Redness', 'timeFrame': 'at specified timepoints for up to 30 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.\n\nIt is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be at least 18 years of age;\n* If female, cannot be not pregnant or nursing\n* Have a positive skin test reaction to cat hair, cat dander, grasses, ragweed, dog dander, cockroach, dust mite, and/or trees within the past 24 months;\n* Have a calculated best corrected visual acuity of 0.6 logMAR or better in each eye as measured using an ETDRS chart;\n\nExclusion Criteria:\n\n* Have known contraindications or sensitivities to the use of any of the study medications(s) or their components;\n* Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety;\n* Have a presence of active ocular infection;\n* Use specified disallowed medications during the study or appropriate pre-study washout period;\n* Have any significant illness;\n* Have planned surgery (ocular or systemic) during the trial period or within 30 days after;\n* Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;\n* Be a female who is currently pregnant or nursing."}, 'identificationModule': {'nctId': 'NCT01275105', 'briefTitle': 'A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eye Therapies, LLC'}, 'officialTitle': 'A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)', 'orgStudyIdInfo': {'id': '10-100-0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Vehicle', 'interventionNames': ['Drug: Vehicle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brimonidine Tartrate 0.01%', 'interventionNames': ['Drug: Brimonidine Tartrate 0.01%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxymetazoline HCl 0.025%', 'interventionNames': ['Drug: Oxymetazoline HCl 0.025%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brimonidine Tartrate 0.025%', 'interventionNames': ['Drug: Brimonidine Tartrate 0.025%']}], 'interventions': [{'name': 'Vehicle', 'type': 'DRUG', 'description': 'one drop in each eye at designated visits', 'armGroupLabels': ['Vehicle']}, {'name': 'Brimonidine Tartrate 0.01%', 'type': 'DRUG', 'description': 'one drop in each eye at designated visits', 'armGroupLabels': ['Brimonidine Tartrate 0.01%']}, {'name': 'Brimonidine Tartrate 0.025%', 'type': 'DRUG', 'description': 'one drop in each eye at designated visits', 'armGroupLabels': ['Brimonidine Tartrate 0.025%']}, {'name': 'Oxymetazoline HCl 0.025%', 'type': 'DRUG', 'description': 'one drop in each eye at designated visits', 'armGroupLabels': ['Oxymetazoline HCl 0.025%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ora, Inc.', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eye Therapies, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}