Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-04-06 @ 10:44 AM
Study NCT ID:
NCT01733732
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2012-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Abayomi Ogundele, Pharm.D, Global Brand Medical Affairs Lead', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected for the duration of the study (7 months). This analysis group includes all subjects exposed to the test product.', 'description': 'An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reports of AEs were obtained through volunteered and elicited comments from the subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Metastasis to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'Change from baseline at Day 14, n=25, 27', 'categories': [{'measurements': [{'value': '-7.85', 'spread': '18.19', 'groupId': 'OG000'}, {'value': '-12.58', 'spread': '19.05', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Day 30, n=27, 27', 'categories': [{'measurements': [{'value': '-10.23', 'spread': '21.72', 'groupId': 'OG000'}, {'value': '-16.74', 'spread': '21.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': "The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'Change from baseline at Day 14, n=50, 53', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Day 30, n=54, 51', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Eyes With Normal Slit-lamp Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance, Day 0', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Balance, Day 14', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG002', 'title': 'Systane Balance, Day 30', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG003', 'title': 'Systane Gel, Day 0', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG004', 'title': 'Systane Gel, Day 14', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG005', 'title': 'Systane Gel, Day 30', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'Orbit / Lids', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}]}]}, {'title': 'Conjunctiva', 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000'}, {'value': '96.0', 'groupId': 'OG001'}, {'value': '96.3', 'groupId': 'OG002'}, {'value': '96.3', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Cornea', 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000'}, {'value': '92.0', 'groupId': 'OG001'}, {'value': '92.6', 'groupId': 'OG002'}, {'value': '92.6', 'groupId': 'OG003'}, {'value': '92.6', 'groupId': 'OG004'}, {'value': '92.6', 'groupId': 'OG005'}]}]}, {'title': 'Anterior chamber', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Iris', 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}, {'value': '94.0', 'groupId': 'OG001'}, {'value': '94.4', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Lens', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '44.0', 'groupId': 'OG001'}, {'value': '44.4', 'groupId': 'OG002'}, {'value': '51.9', 'groupId': 'OG003'}, {'value': '51.9', 'groupId': 'OG004'}, {'value': '51.9', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.'}, {'type': 'SECONDARY', 'title': 'Meibomian Gland Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'Baseline (Day 0), n=54, 54', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, n=50, 54', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, n=54, 54', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'Change from baseline at Day 14, n=45, 54', 'categories': [{'measurements': [{'value': '0.587', 'spread': '6.696', 'groupId': 'OG000'}, {'value': '-0.325', 'spread': '4.557', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Day 30, n=49, 52', 'categories': [{'measurements': [{'value': '-0.914', 'spread': '5.697', 'groupId': 'OG000'}, {'value': '1.261', 'spread': '6.633', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'Change from baseline at Day 14, n=50, 54', 'categories': [{'measurements': [{'value': '0.146', 'spread': '0.165', 'groupId': 'OG000'}, {'value': '0.089', 'spread': '0.181', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Day 30, n=54, 52', 'categories': [{'measurements': [{'value': '0.140', 'spread': '0.168', 'groupId': 'OG000'}, {'value': '0.165', 'spread': '0.242', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Ocular Surface Staining by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance, Change From Baseline at Day 14', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Balance, Change From Baseline at Day 30', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG002', 'title': 'Systane Gel, Change From Baseline at Day 14', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG003', 'title': 'Systane Gel, Change From Baseline at Day 30', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'Corneal staining', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '2.4', 'groupId': 'OG003'}]}]}, {'title': 'Conjunctival staining', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '1.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'IFN-gamma, n=24, 25', 'categories': [{'measurements': [{'value': '2.680', 'spread': '14.366', 'groupId': 'OG000'}, {'value': '15.146', 'spread': '65.229', 'groupId': 'OG001'}]}]}, {'title': 'IL-1beta, n=24, 25', 'categories': [{'measurements': [{'value': '0.192', 'spread': '1.161', 'groupId': 'OG000'}, {'value': '0.335', 'spread': '2.515', 'groupId': 'OG001'}]}]}, {'title': 'IL-6, n=24, 25', 'categories': [{'measurements': [{'value': '0.902', 'spread': '5.009', 'groupId': 'OG000'}, {'value': '0.735', 'spread': '16.364', 'groupId': 'OG001'}]}]}, {'title': 'TNF-alpha, n=24, 25', 'categories': [{'measurements': [{'value': '-0.058', 'spread': '1.713', 'groupId': 'OG000'}, {'value': '0.693', 'spread': '5.727', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 30', 'description': 'A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.751', 'spread': '1.934', 'groupId': 'OG000'}, {'value': '-0.300', 'spread': '0.844', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 30', 'description': 'Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.', 'unitOfMeasure': 'percentage of cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'HLA-DR, n=19, 25', 'categories': [{'measurements': [{'value': '0.079', 'spread': '2.199', 'groupId': 'OG000'}, {'value': '0.019', 'spread': '1.027', 'groupId': 'OG001'}]}]}, {'title': 'TNF-alpha, n=20, 23', 'categories': [{'measurements': [{'value': '-0.061', 'spread': '0.313', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.140', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 30', 'description': 'Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.', 'unitOfMeasure': 'percentage of cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'Change from baseline at Day 14, n=50, 54', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Day 30, n=54, 54', 'categories': [{'measurements': [{'value': '4.6', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '8.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': "Dry eye status was assessed using the Schirmer's test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.", 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Intraocular Pressure (IOP) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'OG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'classes': [{'title': 'Change from baseline at Day 14, n=50, 54', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Day 30, n=54, 54', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'FG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not attend all study visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 1 study center located in the US.', 'preAssignmentDetails': 'A total of 54 subjects were screened and randomized. This reporting group includes all randomized subjects (54).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Systane Balance', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'BG001', 'title': 'Systane Gel', 'description': 'One drop in each eye 4 times a day for 30 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '63.0', 'spread': '13.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis group includes all randomized subjects.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2012-11-21', 'resultsFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-10-31', 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': "The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort."}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean.'}, {'measure': 'Percentage of Eyes With Normal Slit-lamp Assessment', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation.'}, {'measure': 'Meibomian Gland Expression', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean.'}, {'measure': 'Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.'}, {'measure': 'Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.'}, {'measure': 'Mean Change From Baseline in Ocular Surface Staining by Visit', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.'}, {'measure': 'Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30', 'timeFrame': 'Baseline (Day 0), Day 30', 'description': 'A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.'}, {'measure': 'Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30', 'timeFrame': 'Baseline (Day 0), Day 30', 'description': 'Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.'}, {'measure': 'Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30', 'timeFrame': 'Baseline (Day 0), Day 30', 'description': 'Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.'}, {'measure': "Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit", 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': "Dry eye status was assessed using the Schirmer's test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean."}, {'measure': 'Mean Change From Baseline in Intraocular Pressure (IOP) by Visit', 'timeFrame': 'Baseline (Day 0), Day 14, Day 30', 'description': 'IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry eye', 'Lipid deficiency', 'Inflammatory markers'], 'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Read, sign, and date the Informed Consent Document;\n* Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;\n* Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);\n* Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months;\n* Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);\n* History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;\n* Use of any concomitant topical ocular medications during the study period;\n* Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire study period;\n* Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1 and that remains stable throughout the study;\n* Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular condition that may preclude the safe administration of either drop under investigation;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01733732', 'briefTitle': 'SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Study to Evaluate the Efficacy of SYSTANE® BALANCE in Reducing Symptoms and Inflammatory Biomarker Expression of HLA-DR and Tear Film Cytokines in Dry Eye Subjects With Lipid Deficiency', 'orgStudyIdInfo': {'id': 'A00976'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Systane Balance', 'description': 'SYSTANE® BALANCE Lubricant Eye Drops, 1 drop in each eye 4 times a day for 30 days', 'interventionNames': ['Other: SYSTANE® BALANCE Lubricant Eye Drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Systane Gel', 'description': 'SYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days', 'interventionNames': ['Other: SYSTANE® Gel']}], 'interventions': [{'name': 'SYSTANE® BALANCE Lubricant Eye Drops', 'type': 'OTHER', 'otherNames': ['SYSTANE® BALANCE'], 'armGroupLabels': ['Systane Balance']}, {'name': 'SYSTANE® Gel', 'type': 'OTHER', 'armGroupLabels': ['Systane Gel']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Abayomi Ogundele, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}, {'name': 'Penny A. Asbell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}