Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-01 @ 1:49 PM
Study NCT ID:
NCT01534195
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2012-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'klane@oraclinical.com', 'phone': '9786896500', 'title': 'Keith Lane', 'organization': 'Ora'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from the date of informed consent to the date of the final visit (1 month).', 'eventGroups': [{'id': 'EG000', 'title': 'Prednisolone', 'description': 'Prednisolone Sodium Phosphate Ophthalmic Solution, 1%\n\nPrednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 8 days.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Tears Naturale II Ophthalmic Solution, 1%\n\nTears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 8 days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mucous Discharge (OU)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Backache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Itching Change From Baseline to Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisolone', 'description': 'Prednisolone Sodium Phosphate Ophthalmic Solution, 1%\n\nPrednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tears Naturale II Ophthalmic Solution, 1%\n\nTears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes post-CAC', 'description': 'Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Conjunctival Redness Change From Baseline to Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisolone', 'description': 'Prednisolone Sodium Phosphate Ophthalmic Solution, 1%\n\nPrednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tears Naturale II Ophthalmic Solution, 1%\n\nTears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 Minutes post-CAC', 'description': 'Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Episcleral Redness Change From Baseline to Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisolone', 'description': 'Prednisolone Sodium Phosphate Ophthalmic Solution, 1%\n\nPrednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tears Naturale II Ophthalmic Solution, 1%\n\nTears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 minutes post-CAC', 'description': 'Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Ciliary Redness Change From Baseline to Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisolone', 'description': 'Prednisolone Sodium Phosphate Ophthalmic Solution, 1%\n\nPrednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Tears Naturale II Ophthalmic Solution, 1%\n\nTears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.94', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 minutes post-CAC', 'description': 'Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prednisolone', 'description': 'Prednisolone Sodium Phosphate Ophthalmic Solution, 1%\n\nPrednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye four times/day (QID) for 8 days.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Tears Naturale II Ophthalmic Solution, 1%\n\nTears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prednisolone', 'description': 'Prednisolone Sodium Phosphate Ophthalmic Solution, 1%\n\nPrednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Tears Naturale II Ophthalmic Solution, 1%\n\nTears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'spread': '6.693', 'groupId': 'BG000'}, {'value': '49.5', 'spread': '13.329', 'groupId': 'BG001'}, {'value': '49.55', 'spread': '8.896', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2012-01-25', 'resultsFirstSubmitDate': '2018-12-27', 'studyFirstSubmitQcDate': '2012-02-13', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-27', 'studyFirstPostDateStruct': {'date': '2012-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Itching Change From Baseline to Day 11', 'timeFrame': '5 minutes post-CAC', 'description': 'Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).'}], 'secondaryOutcomes': [{'measure': 'Conjunctival Redness Change From Baseline to Day 11', 'timeFrame': '7 Minutes post-CAC', 'description': 'Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)'}, {'measure': 'Episcleral Redness Change From Baseline to Day 6', 'timeFrame': '7 minutes post-CAC', 'description': 'Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).'}, {'measure': 'Ciliary Redness Change From Baseline to Day 6', 'timeFrame': '7 minutes post-CAC', 'description': 'Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,\n\nPrednisolone, assessed by the following measures:\n\n* Ocular itching\n* Conjunctival redness', 'detailedDescription': 'Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 8 days between Visits 4 and 5.\n\n* Prednisolone phosphate\n* Tears Naturale II Ophthalmic Solution (Placebo)\n\nDuration:\n\nApproximately 19 days\n\nControls:\n\nArtificial Tears (Tears Naturale® II)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age \\& either sex, any race\n* Willing and able to follow all instructions\n* Positive history of ocular allergies\n* Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge\n\nExclusion Criteria:\n\n* Have planned surgery during trial period\n* Female currently pregnant, planning a pregnancy or lactating\n* Use of disallowed medications\n* Have ocular infections, or ocular conditions that could affect study parameters\n* Have moderate to severe dry eye\n* Have used an investigational drug or device within 30 days of start of study\n* Female that is currently pregnant, planning a pregnancy or lactating'}, 'identificationModule': {'nctId': 'NCT01534195', 'briefTitle': 'Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model', 'organization': {'class': 'INDUSTRY', 'fullName': 'ORA, Inc.'}, 'officialTitle': 'A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model', 'orgStudyIdInfo': {'id': '12-270-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prednisolone', 'description': 'Prednisolone Sodium Phosphate Ophthalmic Solution, 1%', 'interventionNames': ['Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Tears Naturale II Ophthalmic Solution, 1%', 'interventionNames': ['Drug: Tears Naturale II Ophthalmic Solution']}], 'interventions': [{'name': 'Prednisolone Sodium Phosphate Ophthalmic Solution 1%', 'type': 'DRUG', 'description': 'One drop in each eye, four times/day for 8 days.', 'armGroupLabels': ['Prednisolone']}, {'name': 'Tears Naturale II Ophthalmic Solution', 'type': 'DRUG', 'description': 'one drop in each eye, four times/ day (QID) for 8 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'overallOfficials': [{'name': 'Tarek Shazly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic society of Egypt, Egyptian Glaucoma Society, American Acadamy of Ophthalmology, American Glaucoma Society, The association for research in vision and ophthalmology, international society of refractive surgery, Pan Arab Glaucoma Society'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ORA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}