Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-05 @ 1:09 AM
Study NCT ID:
NCT00938704
Status:
COMPLETED
Last Update Posted:
2011-10-31
First Post:
2009-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
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': 'D002266', 'term': 'Carboxymethylcellulose Sodium'}], 'ancestors': [{'id': 'D008747', 'term': 'Methylcellulose'}, {'id': 'D002482', 'term': 'Cellulose'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs', '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': 'Carboxymethylcellulose 0.5%, Glycerin 0.9%', 'description': 'carboxymethylcellulose 0.5%, glycerin 0.9%', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sodium Hyaluronate 0.18%', 'description': 'sodium hyaluronate 0.18%', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboxymethylcellulose 0.5%, Glycerin 0.9%', 'description': 'carboxymethylcellulose 0.5%, glycerin 0.9%'}, {'id': 'OG001', 'title': 'Sodium Hyaluronate 0.18%', 'description': 'sodium hyaluronate 0.18%'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '56.06', 'spread': '13.43', 'groupId': 'OG000'}, {'value': '54.292', 'spread': '13.100', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-27.048', 'spread': '17.87', 'groupId': 'OG000'}, {'value': '-28.303', 'spread': '21.821', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2', 'description': 'Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tear Breakup Time (TBUT) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboxymethylcellulose 0.5%, Glycerin 0.9%', 'description': 'carboxymethylcellulose 0.5%, glycerin 0.9%'}, {'id': 'OG001', 'title': 'Sodium Hyaluronate 0.18%', 'description': 'sodium hyaluronate 0.18%'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.501', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '5.914', 'spread': '1.646', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '2.919', 'spread': '2.388', 'groupId': 'OG000'}, {'value': '2.538', 'spread': '2.923', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2', 'description': 'Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Corneal Staining at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboxymethylcellulose 0.5%, Glycerin 0.9%', 'description': 'carboxymethylcellulose 0.5%, glycerin 0.9%'}, {'id': 'OG001', 'title': 'Sodium Hyaluronate 0.18%', 'description': 'sodium hyaluronate 0.18%'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.818', 'spread': '0.779', 'groupId': 'OG000'}, {'value': '1.608', 'spread': '0.936', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-1.288', 'spread': '0.718', 'groupId': 'OG000'}, {'value': '-1.23', 'spread': '1.090', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2', 'description': 'Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Staining (Temporal) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboxymethylcellulose 0.5%, Glycerin 0.9%', 'description': 'carboxymethylcellulose 0.5%, glycerin 0.9%'}, {'id': 'OG001', 'title': 'Sodium Hyaluronate 0.18%', 'description': 'sodium hyaluronate 0.18%'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.818', 'spread': '0.950', 'groupId': 'OG000'}, {'value': '1.919', 'spread': '1.010', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-1.152', 'spread': '0.972', 'groupId': 'OG000'}, {'value': '-1.216', 'spread': '1.084', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2', 'description': 'Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Staining (Nasal) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboxymethylcellulose 0.5%, Glycerin 0.9%', 'description': 'carboxymethylcellulose 0.5%, glycerin 0.9%'}, {'id': 'OG001', 'title': 'Sodium Hyaluronate 0.18%', 'description': 'sodium hyaluronate 0.18%'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.758', 'spread': '0.902', 'groupId': 'OG000'}, {'value': '2.000', 'spread': '0.913', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-1.061', 'spread': '0.899', 'groupId': 'OG000'}, {'value': '-1.459', 'spread': '1.043', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2', 'description': 'Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carboxymethylcellulose 0.5%, Glycerin 0.9%', 'description': 'carboxymethylcellulose 0.5%, glycerin 0.9%'}, {'id': 'FG001', 'title': 'Sodium Hyaluronate 0.18%', 'description': 'sodium hyaluronate 0.18%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Carboxymethylcellulose 0.5%, Glycerin 0.9%', 'description': 'carboxymethylcellulose 0.5%, glycerin 0.9%'}, {'id': 'BG001', 'title': 'Sodium Hyaluronate 0.18%', 'description': 'sodium hyaluronate 0.18%'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.386', 'groupId': 'BG000', 'lowerLimit': '20.277', 'upperLimit': '87.485'}, {'value': '48.787', 'groupId': 'BG001', 'lowerLimit': '18.942', 'upperLimit': '84.482'}, {'value': '51.5865', 'groupId': 'BG002', 'lowerLimit': '18.942', 'upperLimit': '87.485'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-22', 'studyFirstSubmitDate': '2009-07-10', 'resultsFirstSubmitDate': '2011-09-22', 'studyFirstSubmitQcDate': '2009-07-10', 'lastUpdatePostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-22', 'studyFirstPostDateStruct': {'date': '2009-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2', 'timeFrame': 'Baseline, Week 2', 'description': 'Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Tear Breakup Time (TBUT) at Week 2', 'timeFrame': 'Baseline, Week 2', 'description': 'Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Corneal Staining at Week 2', 'timeFrame': 'Baseline, Week 2', 'description': 'Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Conjunctival Staining (Temporal) at Week 2', 'timeFrame': 'Baseline, Week 2', 'description': 'Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Conjunctival Staining (Nasal) at Week 2', 'timeFrame': 'Baseline, Week 2', 'description': 'Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).\n* Be likely to complete the entire course of study and to comply with appropriate instructions\n\nExclusion Criteria:\n\n* Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.\n* Have uncontrolled systemic disease\n* Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears\n* Have anticipated contact lens wear during the study\n* Have an active ocular infection'}, 'identificationModule': {'nctId': 'NCT00938704', 'briefTitle': 'Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MA-OPT-09-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'carboxymethylcellulose 0.5%, glycerin 0.9%', 'interventionNames': ['Drug: carboxymethylcellulose 0.5% +glycerin 0.9%']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'sodium hyaluronate 0.18%', 'interventionNames': ['Drug: sodium hyaluronate 0.18%']}], 'interventions': [{'name': 'carboxymethylcellulose 0.5% +glycerin 0.9%', 'type': 'DRUG', 'otherNames': ['Optive™ Sensitive'], 'description': 'To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.', 'armGroupLabels': ['1']}, {'name': 'sodium hyaluronate 0.18%', 'type': 'DRUG', 'otherNames': ['Vismed®'], 'description': 'To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulm', 'country': 'Germany', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}