Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT01682460
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2012-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cclr2@sciborg.uwaterloo.ca', 'phone': '519-888-4742', 'title': 'Research Manager', 'organization': 'CCLR'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month', 'otherNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Corneal marginal keratitis', 'notes': 'Unrelated to study drops', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Surface Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'spread': '0.80', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (dispensing visit)', 'description': 'Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \\>30 dots + confluence', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ocular Surface Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '1.55', 'spread': '0.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 week', 'description': 'Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \\>30 dots + confluence', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ocular Surface Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '1.29', 'spread': '0.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 month', 'description': 'Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \\>30 dots + confluence', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tear Break up Time With Fluorescein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '2.88', 'spread': '2.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (dispensing visit)', 'description': 'The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tear Break up Time With Fluorescein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '3.41', 'spread': '2.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 week', 'description': 'The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tear Break up Time With Fluorescein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '4.01', 'spread': '2.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 month', 'description': 'The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ocular Surface Disease Index (OSDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (dispensing visit)', 'description': 'The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = \\[(sum of scores for all questions answered)\\*100\\] / \\[(total number of questions answered)\\*4\\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Ratings of Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (dispensing visit)', 'description': 'Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ocular Surface Disease Index (OSDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'spread': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week after using artificial tears', 'description': 'The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = \\[(sum of scores for all questions answered)\\*100\\] / \\[(total number of questions answered)\\*4\\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ocular Surface Disease Index (OSDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month after using artificial tears', 'description': 'The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = \\[(sum of scores for all questions answered)\\*100\\] / \\[(total number of questions answered)\\*4\\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Ratings of Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'spread': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week after using artificial tears', 'description': 'Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Ratings of Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month after using artificial tears', 'description': 'Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month\n\nRefresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2012-08-29', 'resultsFirstSubmitDate': '2014-05-14', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-02', 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subjective Ratings of Comfort', 'timeFrame': 'At baseline (dispensing visit)', 'description': 'Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)'}, {'measure': 'Subjective Ratings of Comfort', 'timeFrame': '1 week after using artificial tears', 'description': 'Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)'}, {'measure': 'Subjective Ratings of Comfort', 'timeFrame': '1 month after using artificial tears', 'description': 'Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)'}], 'primaryOutcomes': [{'measure': 'Ocular Surface Staining', 'timeFrame': 'At baseline (dispensing visit)', 'description': 'Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \\>30 dots + confluence'}, {'measure': 'Ocular Surface Staining', 'timeFrame': 'After 1 week', 'description': 'Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \\>30 dots + confluence'}, {'measure': 'Ocular Surface Staining', 'timeFrame': 'After 1 month', 'description': 'Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \\>30 dots + confluence'}, {'measure': 'Tear Break up Time With Fluorescein', 'timeFrame': 'At baseline (dispensing visit)', 'description': 'The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .'}, {'measure': 'Tear Break up Time With Fluorescein', 'timeFrame': 'After 1 week', 'description': 'The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .'}, {'measure': 'Tear Break up Time With Fluorescein', 'timeFrame': 'After 1 month', 'description': 'The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .'}], 'secondaryOutcomes': [{'measure': 'Ocular Surface Disease Index (OSDI) Score', 'timeFrame': 'At baseline (dispensing visit)', 'description': 'The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = \\[(sum of scores for all questions answered)\\*100\\] / \\[(total number of questions answered)\\*4\\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).'}, {'measure': 'Ocular Surface Disease Index (OSDI) Score', 'timeFrame': '1 week after using artificial tears', 'description': 'The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = \\[(sum of scores for all questions answered)\\*100\\] / \\[(total number of questions answered)\\*4\\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).'}, {'measure': 'Ocular Surface Disease Index (OSDI) Score', 'timeFrame': '1 month after using artificial tears', 'description': 'The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = \\[(sum of scores for all questions answered)\\*100\\] / \\[(total number of questions answered)\\*4\\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma', 'Dry Eyes']}, 'descriptionModule': {'briefSummary': 'Research indicates that many people who are being treated for glaucoma have dry eyes. The purpose of this study is to test the use of artificial tears to alleviate dryness signs and symptoms in people who are using medication to treat glaucoma. The study hypothesis is that the use of artificial tears will result in an improvement in clinical signs and symptoms associated with dry eyes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 17 years of age and has full legal capacity to volunteer;\n* Has read and signed an information consent letter;\n* Is willing and able to follow instructions and maintain the appointment schedule;\n* Is a current non-contact lens wearer.\n* Has previously been diagnosed with primary open angle glaucoma and is currently being treated with a topical therapeutic agent.\n* The glaucoma medication dosage and usage must have been the same for \\>6 months.\n* Shows a minimum score of 2 (sometimes) on the SESOD questionnaire.\n* Distance VA of at least 20/40 in each eye with current spectacle correction.\n\nExclusion Criteria:\n\n* Is participating in any concurrent clinical or research study;\n* Has any known active\\* ocular disease and/or infection; except primary open angle glaucoma.\n* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;\n* Is using any systemic or topical medications (with the exception of glaucoma medication) that in the opinion of the investigator may affect a study outcome variable;\n* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;\n* Is pregnant, lactating or planning a pregnancy at the time of enrolment;\n* Has undergone refractive error surgery;\n* Is an employee of the Centre for Contact Lens Research;\n* Has taken part in another (pharmaceutical) research study within the last 30 days;\n* Is currently using artificial tears more than 3 times per day.\n\n * For the purposes of this study, active ocular disease is defined as infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.'}, 'identificationModule': {'nctId': 'NCT01682460', 'acronym': 'IVES', 'briefTitle': 'Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Waterloo'}, 'officialTitle': 'Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients', 'orgStudyIdInfo': {'id': '18262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'description': 'Artificial tears eye drops QID for 1 month', 'interventionNames': ['Drug: Refresh Tears Lubricant Eye Drops (Allergan)']}], 'interventions': [{'name': 'Refresh Tears Lubricant Eye Drops (Allergan)', 'type': 'DRUG', 'description': 'Eye drops QID for 1 month', 'armGroupLabels': ['Refresh Tears Lubricant Eye Drops (Allergan)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Contact Lens Research, University of Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Lyndon Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Waterloo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}