Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-29 @ 2:36 PM
Study NCT ID:
NCT01326858
Status:
COMPLETED
Last Update Posted:
2015-03-03
First Post:
2011-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Comfort of AL-4943A Ophthalmic Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069605', 'term': 'Olopatadine Hydrochloride'}, {'id': 'C514418', 'term': 'ketotifen fumarate ophthalmic solution'}], 'ancestors': [{'id': 'D003990', 'term': 'Dibenzoxepins'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-27', 'studyFirstSubmitDate': '2011-03-30', 'studyFirstSubmitQcDate': '2011-03-30', 'lastUpdatePostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak discomfort score over a 3-minute period after drop instillation', 'timeFrame': 'Up to Day 3', 'description': 'Ocular discomfort as measured by Visual Analog Scale (VAS) with 0=none to 50=severe, was assessed by subjects every 30 seconds between 0 to 180 seconds after drop instillation (at 0, 30, 60, 90, 120, 150, and 180 seconds). Peak discomfort (maximum observed VAS discomfort score over the 3-minute period) for each subject in each period was analyzed.'}], 'secondaryOutcomes': [{'measure': 'Ocular Symptoms', 'timeFrame': 'Up to Day 3', 'description': 'Ocular symptoms (burning, stinging, tearing, blurring, and stickiness) assessed by the subject after instillation of drop as a single score where 0=none to 9=severe.'}, {'measure': 'Product Acceptability', 'timeFrame': 'Up to Day 3', 'description': 'Product Acceptability assessed by the subject after instillation of drop as a single score where 0=very acceptable and 100=not acceptable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ocular discomfort', 'AL-4943A Ophthalmic Solution'], 'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.', 'detailedDescription': 'In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits.\n* Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease.\n* History of any clinically significant external ocular disease within 30 days of the start of the study.\n* Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01326858', 'briefTitle': 'Safety and Comfort of AL-4943A Ophthalmic Solution', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%', 'orgStudyIdInfo': {'id': 'C-10-127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olopatadine, 0.7%', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized', 'interventionNames': ['Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%', 'Drug: Olopatadine hydrochloride ophthalmic solution vehicle', 'Drug: Ketotifen fumarate ophthalmic solution, 0.025%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized', 'interventionNames': ['Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%', 'Drug: Olopatadine hydrochloride ophthalmic solution vehicle', 'Drug: Ketotifen fumarate ophthalmic solution, 0.025%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zaditor', 'description': 'Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized', 'interventionNames': ['Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%', 'Drug: Olopatadine hydrochloride ophthalmic solution vehicle', 'Drug: Ketotifen fumarate ophthalmic solution, 0.025%']}], 'interventions': [{'name': 'Olopatadine hydrochloride ophthalmic solution, 0.7%', 'type': 'DRUG', 'otherNames': ['AL-4943A'], 'description': 'Treatment A', 'armGroupLabels': ['Olopatadine, 0.7%', 'Vehicle', 'Zaditor']}, {'name': 'Olopatadine hydrochloride ophthalmic solution vehicle', 'type': 'DRUG', 'description': 'Treatment B, inactive ingredients used as placebo', 'armGroupLabels': ['Olopatadine, 0.7%', 'Vehicle', 'Zaditor']}, {'name': 'Ketotifen fumarate ophthalmic solution, 0.025%', 'type': 'DRUG', 'otherNames': ['Zaditor®'], 'description': 'Treatment C', 'armGroupLabels': ['Olopatadine, 0.7%', 'Vehicle', 'Zaditor']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Abhijit Narvekar, MS, MBBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}