Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-09 @ 4:15 PM
Study NCT ID:
NCT00611403
Status:
COMPLETED
Last Update Posted:
2011-12-20
First Post:
2008-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003524', 'term': 'Cyclosporins'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head', 'organization': 'Allergan, Inc.'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'RESTASIS®', 'description': 'Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)', 'otherNumAtRisk': 68, 'otherNumAffected': 16, 'seriousNumAtRisk': 68, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'REFRESH ENDURA®', 'description': 'Artificial Tears (REFRESH ENDURA®)', 'otherNumAtRisk': 69, 'otherNumAffected': 8, 'seriousNumAtRisk': 69, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Colon cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Infected bites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Clinical Success at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RESTASIS®', 'description': 'Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)'}, {'id': 'OG001', 'title': 'REFRESH ENDURA®', 'description': 'Artificial Tears (REFRESH ENDURA®)'}], 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}, {'value': '58.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) \\>= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT). The mITT population included all randomized and treated patients with a study eye having a corneal sensitivity measurement of \\< 25 mm in the 3 central regions of the eye on Day 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RESTASIS®', 'description': 'Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)'}, {'id': 'OG001', 'title': 'REFRESH ENDURA®', 'description': 'Artificial Tears (REFRESH ENDURA®)'}], 'classes': [{'title': 'Better Eye: Baseline', 'categories': [{'measurements': [{'value': '28095.7', 'spread': '5303.28', 'groupId': 'OG000'}, {'value': '26069.5', 'spread': '4648.48', 'groupId': 'OG001'}]}]}, {'title': 'Better Eye: Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '901.6', 'spread': '6117.69', 'groupId': 'OG000'}, {'value': '1346.6', 'spread': '5550.24', 'groupId': 'OG001'}]}]}, {'title': 'Worse Eye: Baseline', 'categories': [{'measurements': [{'value': '26489.9', 'spread': '5161.53', 'groupId': 'OG000'}, {'value': '27480.6', 'spread': '4854.00', 'groupId': 'OG001'}]}]}, {'title': 'Worse Eye: Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '3011.7', 'spread': '7931.29', 'groupId': 'OG000'}, {'value': '-218.4', 'spread': '5799.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).', 'unitOfMeasure': 'Cells per cubic millimeter (cells/mm^3)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Goblet Cell Density of the Eyes at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RESTASIS®', 'description': 'Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)'}, {'id': 'OG001', 'title': 'REFRESH ENDURA®', 'description': 'Artificial Tears (REFRESH ENDURA®)'}], 'classes': [{'title': 'Better Eye: Baseline', 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '291'}, {'value': '59.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '193'}]}]}, {'title': 'Better Eye: Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '-284', 'upperLimit': '115'}, {'value': '-3.1', 'groupId': 'OG001', 'lowerLimit': '-145', 'upperLimit': '222'}]}]}, {'title': 'Worse Eye: Baseline', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '276'}, {'value': '79.2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '237'}]}]}, {'title': 'Worse Eye: Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '-96', 'upperLimit': '222'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '-175', 'upperLimit': '208'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).', 'unitOfMeasure': 'Cells per square millimeter (cells/mm^2)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RESTASIS®', 'description': 'Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)'}, {'id': 'FG001', 'title': 'REFRESH ENDURA®', 'description': 'Artificial Tears (REFRESH ENDURA®)'}], 'periods': [{'title': 'Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}, {'title': 'Post Treatment Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '26 of 68 pts who received RESTASIS® in the Treatment Phase entered the Post Treatment Ext. Phase', 'groupId': 'FG000', 'numSubjects': '26'}, {'comment': '25 of 69 pts who received ENDURA® in the Treatment Phase entered the Post Treatment Extension Phase', 'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RESTASIS®', 'description': 'Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)'}, {'id': 'BG001', 'title': 'REFRESH ENDURA®', 'description': 'Artificial Tears (REFRESH ENDURA®)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 30 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Between 30 and 40 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': '> 40 years', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-17', 'studyFirstSubmitDate': '2008-01-28', 'resultsFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2008-02-07', 'lastUpdatePostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-17', 'studyFirstPostDateStruct': {'date': '2008-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Clinical Success at Month 6', 'timeFrame': 'Month 6', 'description': 'Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) \\>= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).'}, {'measure': 'Change From Baseline in Goblet Cell Density of the Eyes at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).'}]}, 'conditionsModule': {'keywords': ['LASIK'], 'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is scheduled for bilateral LASIK surgery\n* Patient is in good general health\n* Eye glasses prescription of -1 to -8\n\nExclusion Criteria:\n\n* Significant Dry Eye\n* Presence of eye disease\n* Uncontrolled systemic disease'}, 'identificationModule': {'nctId': 'NCT00611403', 'briefTitle': 'Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients', 'orgStudyIdInfo': {'id': '192371-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RESTASIS®', 'description': 'Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)', 'interventionNames': ['Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'REFRESH ENDURA®', 'description': 'Artificial Tears (REFRESH ENDURA®)', 'interventionNames': ['Drug: Artificial Tears REFRESH ENDURA®']}], 'interventions': [{'name': 'Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)', 'type': 'DRUG', 'description': 'Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery', 'armGroupLabels': ['RESTASIS®']}, {'name': 'Artificial Tears REFRESH ENDURA®', 'type': 'DRUG', 'description': 'REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery', 'armGroupLabels': ['REFRESH ENDURA®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}