Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-22 @ 12:47 PM
Study NCT ID:
NCT00991458
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2009-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Cyclosporine in Post-LASIK Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'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'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, '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': 'Cyclosporine 0.010% Eye Drops', 'description': 'Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.', 'otherNumAtRisk': 207, 'otherNumAffected': 78, 'seriousNumAtRisk': 207, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cyclosporine 0.005% Eye Drops', 'description': 'Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.', 'otherNumAtRisk': 209, 'otherNumAffected': 66, 'seriousNumAtRisk': 209, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo (Vehicle for Cyclosporine)', 'description': 'Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.', 'otherNumAtRisk': 205, 'otherNumAffected': 66, 'seriousNumAtRisk': 205, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 47}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.0'}, {'term': 'Punctate Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.0'}], 'seriousEvents': [{'term': 'Clavicle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.0'}, {'term': 'Haemorrhagic Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.0'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.0'}, {'term': 'Refraction Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine 0.010% Eye Drops', 'description': 'Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'OG001', 'title': 'Cyclosporine 0.005% Eye Drops', 'description': 'Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'OG002', 'title': 'Placebo (Vehicle for Cyclosporine)', 'description': 'Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '189.0', 'comment': 'The upper limit was not reached at 6 months.', 'groupId': 'OG000', 'lowerLimit': '181.0', 'upperLimit': 'NA'}, {'value': '194.0', 'groupId': 'OG001', 'lowerLimit': '181.0', 'upperLimit': '196.0'}, {'value': '189.0', 'comment': 'The upper limit was not reached at 6 months.', 'groupId': 'OG002', 'lowerLimit': '180.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 Months', 'description': 'Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat: all randomized and treated patients with both eyes having Post-LASIK surgery and corneal sensitivity measurements of \\< 25 mm in the 3 central regions at Post-Surgery Week 1.'}, {'type': 'SECONDARY', 'title': 'Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine 0.010% Eye Drops', 'description': 'Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'OG001', 'title': 'Cyclosporine 0.005% Eye Drops', 'description': 'Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'OG002', 'title': 'Placebo (Vehicle for Cyclosporine)', 'description': 'Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '4.51', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '4.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 3 to 6', 'description': 'The time to the worst outcome post-LASIK surgery in tear film stability is assessed using the Ocular Scatter Index (OSI). The OSI is calculated by an instrument which takes images of the eye over time. OSI values ≥3.0 indicate lower tear film quality resulting in a loss of visual acuity. The worst outcome post-LASIK surgery is defined as the shortest time to OSI ≥3 across both eyes and post-LASIK surgery months 3 to 6.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population: all randomized patients for whom data are available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Cumulative Poor Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine 0.010% Eye Drops', 'description': 'Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'OG001', 'title': 'Cyclosporine 0.005% Eye Drops', 'description': 'Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'OG002', 'title': 'Placebo (Vehicle for Cyclosporine)', 'description': 'Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}, {'value': '18.7', 'groupId': 'OG001'}, {'value': '19.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}, {'value': '23.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}, {'value': '24.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000'}, {'value': '26.8', 'groupId': 'OG001'}, {'value': '26.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, Month 4, Month 5, Month 6', 'description': 'Cumulative Poor Vision is determined binocularly per patient (using both eyes at the same time) from the Poor Vision question on the Ocular Surface Disease Index (OSDI) questionnaire. Severity of poor vision is graded on a 5-point scale (0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, 4 = all of the time). Cumulative poor vision is defined as at least one poor vision score ≥ 1 beginning at Month 3 post-LASIK.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized patients.'}, {'type': 'SECONDARY', 'title': 'Worst Outcome Post-LASIK Surgery in Reading Speed Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine 0.010% Eye Drops', 'description': 'Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'OG001', 'title': 'Cyclosporine 0.005% Eye Drops', 'description': 'Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'OG002', 'title': 'Placebo (Vehicle for Cyclosporine)', 'description': 'Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '173.0', 'spread': '40.17', 'groupId': 'OG000'}, {'value': '173.7', 'spread': '42.18', 'groupId': 'OG001'}, {'value': '167.4', 'spread': '45.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 3 to 6', 'description': 'Reading speed is determined using the MNREAD™ Reading Card. The MNREAD™ reading card is designed to simulate a normal every day reading scenario using binocular vision (both eyes at the same time). The MNREAD™ Reading speed is calculated as (60) X \\[Number of words on card - (reading errors)\\]/ (number of seconds until the card is read). The worst outcome is defined as the smallest number of words per minute across post-LASIK surgery months 3 to 6.', 'unitOfMeasure': 'Words Per Minute (WPM)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population: all randomized patients for whom data are available for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cyclosporine 0.010% Eye Drops', 'description': 'Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'FG001', 'title': 'Cyclosporine 0.005% Eye Drops', 'description': 'Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'FG002', 'title': 'Placebo (Vehicle for Cyclosporine)', 'description': 'Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '205'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '181'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '25'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '621', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cyclosporine 0.010% Eye Drops', 'description': 'Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'BG001', 'title': 'Cyclosporine 0.005% Eye Drops', 'description': 'Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'BG002', 'title': 'Placebo (Vehicle for Cyclosporine)', 'description': 'Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<30 years', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '214', 'groupId': 'BG003'}]}]}, {'title': '30 to 40 years', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}]}, {'title': '>40 years', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '338', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '283', 'groupId': 'BG003'}]}]}], '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': 621}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'dispFirstSubmitDate': '2012-04-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2009-10-07', 'dispFirstSubmitQcDate': '2012-04-02', 'resultsFirstSubmitDate': '2013-05-02', 'studyFirstSubmitQcDate': '2009-10-07', 'dispFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-09', 'studyFirstPostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Cure', 'timeFrame': '6 Months', 'description': 'Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.'}], 'secondaryOutcomes': [{'measure': 'Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment', 'timeFrame': 'Months 3 to 6', 'description': 'The time to the worst outcome post-LASIK surgery in tear film stability is assessed using the Ocular Scatter Index (OSI). The OSI is calculated by an instrument which takes images of the eye over time. OSI values ≥3.0 indicate lower tear film quality resulting in a loss of visual acuity. The worst outcome post-LASIK surgery is defined as the shortest time to OSI ≥3 across both eyes and post-LASIK surgery months 3 to 6.'}, {'measure': 'Percentage of Patients With Cumulative Poor Vision', 'timeFrame': 'Month 3, Month 4, Month 5, Month 6', 'description': 'Cumulative Poor Vision is determined binocularly per patient (using both eyes at the same time) from the Poor Vision question on the Ocular Surface Disease Index (OSDI) questionnaire. Severity of poor vision is graded on a 5-point scale (0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, 4 = all of the time). Cumulative poor vision is defined as at least one poor vision score ≥ 1 beginning at Month 3 post-LASIK.'}, {'measure': 'Worst Outcome Post-LASIK Surgery in Reading Speed Assessment', 'timeFrame': 'Months 3 to 6', 'description': 'Reading speed is determined using the MNREAD™ Reading Card. The MNREAD™ reading card is designed to simulate a normal every day reading scenario using binocular vision (both eyes at the same time). The MNREAD™ Reading speed is calculated as (60) X \\[Number of words on card - (reading errors)\\]/ (number of seconds until the card is read). The worst outcome is defined as the smallest number of words per minute across post-LASIK surgery months 3 to 6.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Laser In Situ Keratomileusis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops administered twice daily before and 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\n* Previous use of RESTASIS®'}, 'identificationModule': {'nctId': 'NCT00991458', 'briefTitle': 'Study of Cyclosporine in Post-LASIK Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'Study of Cyclosporine in Post-LASIK Patients', 'orgStudyIdInfo': {'id': '192371-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclosporine 0.010% eye drops', 'description': 'Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.', 'interventionNames': ['Drug: Cyclosporine 0.010% eye drops']}, {'type': 'EXPERIMENTAL', 'label': 'Cyclosporine 0.005% eye drops', 'description': 'Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.', 'interventionNames': ['Drug: Cyclosporine 0.005% eye drops']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Vehicle for Cyclosporine)', 'description': 'Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.', 'interventionNames': ['Drug: Placebo (Vehicle for Cyclosporine)']}], 'interventions': [{'name': 'Cyclosporine 0.010% eye drops', 'type': 'DRUG', 'description': 'Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.', 'armGroupLabels': ['Cyclosporine 0.010% eye drops']}, {'name': 'Cyclosporine 0.005% eye drops', 'type': 'DRUG', 'description': 'Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.', 'armGroupLabels': ['Cyclosporine 0.005% eye drops']}, {'name': 'Placebo (Vehicle for Cyclosporine)', 'type': 'DRUG', 'description': 'Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.', 'armGroupLabels': ['Placebo (Vehicle for Cyclosporine)']}]}, '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'}}}}