Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 7:25 PM
Study NCT ID:
NCT03055832
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2017-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080343', 'term': 'Meibomian Gland Dysfunction'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rthornhill@tearfilm.com', 'phone': '844-458-9776', 'title': 'Rob Thornhill', 'organization': 'TearFilm Innovations, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'description': 'Any untoward and unintended sign, symptom or disease temporally associated with the use of an investigational drug or device, or other protocol-imposed intervention, regardless of the suspected cause. Chronic but stable conditions or diseases are not AEs. Changes in a chronic condition or disease consistent with natural disease progression are not AEs. AEs were assessed during procedure, immediately post-procedure, 1 day, 2 weeks, \\& 4 weeks post-procedure.', 'eventGroups': [{'id': 'EG000', 'title': 'iLux 2020 System', 'description': 'Meibomian Gland Treatment\n\niLux 2020 System: Heating and compression to express clogged meibomian glands', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 5, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LipiFlow Thermal Pulsation System', 'description': 'Meibomian Gland Treatment\n\nLipiFlow Pulsation System: Heating and compression to express clogged meibomian glands', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 4, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Other', 'notes': 'Includes: burning sensation, itching, stinging, petechial hemorrhage, superficial punctate keratitis, and blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 4 in Meibomian Gland Score (MGS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}]}, {'units': 'Eyes', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '141', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'iLux Right Eye', 'description': 'Right Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG001', 'title': 'iLux Left Eye', 'description': 'Left Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG002', 'title': 'iLux Both Eyes', 'description': 'Both Eyes of Subjects treated with the iLux 2020 System'}, {'id': 'OG003', 'title': 'LipiFlow Right Eye', 'description': 'Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System'}, {'id': 'OG004', 'title': 'LipiFlow Left Eye', 'description': 'Left Eye of Subjects treated with Lipiflow Thermal Pulsation System'}, {'id': 'OG005', 'title': 'LipiFlow Both Eyes', 'description': 'Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '17.7', 'spread': '12.2', 'groupId': 'OG002'}, {'value': '18.1', 'spread': '10.8', 'groupId': 'OG003'}, {'value': '16.9', 'spread': '11.5', 'groupId': 'OG004'}, {'value': '17.5', 'spread': '11.1', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-3.82', 'ciUpperLimit': '3.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.88', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:\n\n* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%\n* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%\n* Power that both endpoitns are significant, assuming independence was 0.939\\^2 = 0.882 or 88.2% power.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator while viewing the eyelid margin using a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3 for a maximum MGS of 45 in each eye. MGS scoring was as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A positive change value indicates an improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All randomized and treated patients'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 4 in Tear Break-Up Time (TBT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}]}, {'units': 'Eyes', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '142', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'iLux Right Eye', 'description': 'Right Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG001', 'title': 'iLux Left Eye', 'description': 'Left Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG002', 'title': 'iLux Both Eyes', 'description': 'Both Eyes of Subjects treated with the iLux 2020 System'}, {'id': 'OG003', 'title': 'LipiFlow Right Eye', 'description': 'Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System'}, {'id': 'OG004', 'title': 'LipiFlow Left Eye', 'description': 'Left Eye of Subjects treated with Lipiflow Thermal Pulsation System'}, {'id': 'OG005', 'title': 'LipiFlow Both Eyes', 'description': 'Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System'}], 'classes': [{'categories': [{'measurements': [{'value': '2.86', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '3.72', 'groupId': 'OG001'}, {'value': '2.79', 'spread': '3.66', 'groupId': 'OG002'}, {'value': '2.69', 'spread': '3.31', 'groupId': 'OG003'}, {'value': '2.61', 'spread': '3.22', 'groupId': 'OG004'}, {'value': '2.65', 'spread': '3.25', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '1.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:\n\n* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%\n* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%\n* Power that both endpoitns are significant, assuming independence was 0.939\\^2 = 0.882 or 88.2% power.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': "Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBT. A positive change value represents a lengthening in the tear break-up time and greater comfort.", 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All randomized and treated patients'}, {'type': 'PRIMARY', 'title': 'Incidence (Number) of Device- or Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iLux 2020 System', 'description': 'Meibomian Gland Treatment\n\niLux 2020 System: Heating and compression to express clogged meibomian glands'}, {'id': 'OG001', 'title': 'LipiFlow Thermal Pulsation System', 'description': 'Meibomian Gland Treatment\n\nLipiFlow Pulsation System: Heating and compression to express clogged meibomian glands'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "A formal hypothesis was not proposed for this endpoint and therefore a power calculation was not performed. A Fisher's Exact test was performed post hoc to determine if a significant difference existed between the two arms."}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'The number of device- or procedure-related adverse events was calculated, including changes from baseline (Yes/No) in any of the following eyelid characteristics: lid margin assessment or development of floppy eyelids or entropion (eyelid rolled inward) or ectropion (eyelid sagging outward) or loss of lash integrity.', 'unitOfMeasure': 'Adverse event', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated patients'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}, {'value': '70', 'groupId': 'OG006'}, {'value': '71', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'iLux All Questions', 'description': 'All OSDI questions in Subjects treated with the iLux 2020 System'}, {'id': 'OG001', 'title': 'iLux Vision Questions', 'description': 'OSDI Questions 1-5 in Subjects Treated with the iLux 2020 System'}, {'id': 'OG002', 'title': 'iLux Ocular Questions', 'description': 'OSDI questions 6-9 in Subjects treated with the iLux 2020 System'}, {'id': 'OG003', 'title': 'iLux Trigger Questions', 'description': 'OSDI questions 10-12 in Subjects treated with the iLux 2020 System'}, {'id': 'OG004', 'title': 'LipiFlow All Questions', 'description': 'All OSDI questions (1-12) in Subjects treated with the LipiFlow Thermal Pulsation System'}, {'id': 'OG005', 'title': 'LipiFlow Vision Questions', 'description': 'OSDI Questions 1-5 in Subjects treated with the LipiFlow Thermal Pulsation System'}, {'id': 'OG006', 'title': 'LipiFlow Ocular Questions', 'description': 'OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System'}, {'id': 'OG007', 'title': 'LipiFlow Trigger Questions', 'description': 'OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.0', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '-27.3', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '-30.9', 'spread': '25.9', 'groupId': 'OG002'}, {'value': '-37.0', 'spread': '30.6', 'groupId': 'OG003'}, {'value': '-28.0', 'spread': '22.8', 'groupId': 'OG004'}, {'value': '-24.9', 'spread': '20.0', 'groupId': 'OG005'}, {'value': '-27.5', 'spread': '28.4', 'groupId': 'OG006'}, {'value': '-34.4', 'spread': '34.7', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.08', 'ciLowerLimit': '-8.75', 'ciUpperLimit': '2.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.89', 'groupDescription': 'All questions', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A standard deviation of 14 was assumed based on pilot data and the non-inferiority delta was set to 7. The chosen sample size and alpha = 0.025 provides 80% power for this endpoint'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'The Ocular Surface Disease Index (OSDI) is a 12-item, patient-reported outcome questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient\'s vision. Each item is scored on a 0-4 Likert-type scale, where 0 is "None" and 4 is "All of the Time." The OSDI is calculated as the (sum of scores) x 25 / (# of questions answered), for a resultant overall score of 0-100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value indicates an improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated patients'}, {'type': 'SECONDARY', 'title': 'Mean Pain Score During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '70', 'groupId': 'OG005'}]}, {'units': 'Eyes', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '139', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'iLux Right Eye', 'description': 'Right Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG001', 'title': 'iLux Left Eye', 'description': 'Left Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG002', 'title': 'iLux Both Eyes', 'description': 'Both Eyes of Subjects treated with the iLux 2020 System'}, {'id': 'OG003', 'title': 'LipiFlow Right Eye', 'description': 'Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System'}, {'id': 'OG004', 'title': 'LipiFlow Left Eye', 'description': 'Left Eye of Subjects treated with Lipiflow Thermal Pulsation System'}, {'id': 'OG005', 'title': 'LipiFlow Both Eyes', 'description': 'Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '34.4', 'spread': '28.6', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '28.0', 'groupId': 'OG001'}, {'value': '34.2', 'spread': '28.2', 'groupId': 'OG002'}, {'value': '30.8', 'spread': '26.4', 'groupId': 'OG003'}, {'value': '32.6', 'spread': '27.6', 'groupId': 'OG004'}, {'value': '31.7', 'spread': '27.0', 'groupId': 'OG005'}]}]}, {'title': 'Immediately Post-Treatment (Day 0)', 'categories': [{'measurements': [{'value': '25.2', 'spread': '25.1', 'groupId': 'OG000'}, {'value': '23.6', 'spread': '23.7', 'groupId': 'OG001'}, {'value': '24.4', 'spread': '24.3', 'groupId': 'OG002'}, {'value': '10.2', 'spread': '14.6', 'groupId': 'OG003'}, {'value': '10.1', 'spread': '13.8', 'groupId': 'OG004'}, {'value': '10.1', 'spread': '14.1', 'groupId': 'OG005'}]}]}, {'title': 'Day 1 Post-Treatment', 'categories': [{'measurements': [{'value': '12.0', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '17.0', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '16.3', 'groupId': 'OG002'}, {'value': '11.8', 'spread': '17.8', 'groupId': 'OG003'}, {'value': '11.5', 'spread': '16.9', 'groupId': 'OG004'}, {'value': '11.7', 'spread': '17.3', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment', 'description': 'The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no pain, 100 = maximum pain) at the point that indicated the pain in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. A score a 20 was associated with a description of "hurts a little". Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All randomized and treated patients'}, {'type': 'SECONDARY', 'title': 'Mean Discomfort Score During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '70', 'groupId': 'OG005'}]}, {'units': 'Eyes', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '139', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'iLux Right Eye', 'description': 'Right Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG001', 'title': 'iLux Left Eye', 'description': 'Left Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG002', 'title': 'iLux Both Eyes', 'description': 'Both Eyes of Subjects treated with the iLux 2020 System'}, {'id': 'OG003', 'title': 'LipiFlow Right Eye', 'description': 'Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System'}, {'id': 'OG004', 'title': 'LipiFlow Left Eye', 'description': 'Left Eye of Subjects treated with Lipiflow Thermal Pulsation System'}, {'id': 'OG005', 'title': 'LipiFlow Both Eyes', 'description': 'Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '56.3', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '55.9', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '56.1', 'spread': '22.0', 'groupId': 'OG002'}, {'value': '52.1', 'spread': '23.6', 'groupId': 'OG003'}, {'value': '52.6', 'spread': '24.0', 'groupId': 'OG004'}, {'value': '52.3', 'spread': '23.6', 'groupId': 'OG005'}]}]}, {'title': 'Immediately Post-Treatment (Day 0)', 'categories': [{'measurements': [{'value': '38.9', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '22.5', 'groupId': 'OG001'}, {'value': '37.8', 'spread': '23.6', 'groupId': 'OG002'}, {'value': '22.3', 'spread': '21.2', 'groupId': 'OG003'}, {'value': '23.7', 'spread': '21.6', 'groupId': 'OG004'}, {'value': '23.0', 'spread': '21.3', 'groupId': 'OG005'}]}]}, {'title': 'Day 1 Post-Treatment', 'categories': [{'measurements': [{'value': '23.5', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '22.4', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '22.4', 'groupId': 'OG002'}, {'value': '24.7', 'spread': '24.2', 'groupId': 'OG003'}, {'value': '24.4', 'spread': '23.4', 'groupId': 'OG004'}, {'value': '24.5', 'spread': '23.7', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment', 'description': 'The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no discomfort, 100 = maximum discomfort) at the point that indicated the discomfort in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All randomized and treated patients'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-Treatment in Ocular Surface Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '70', 'groupId': 'OG005'}]}, {'units': 'Eyes', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'iLux Right Eye', 'description': 'Right Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG001', 'title': 'iLux Left Eye', 'description': 'Left Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG002', 'title': 'iLux Both Eyes', 'description': 'Both Eyes of Subjects treated with the iLux 2020 System'}, {'id': 'OG003', 'title': 'LipiFlow Right Eye', 'description': 'Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System'}, {'id': 'OG004', 'title': 'LipiFlow Left Eye', 'description': 'Left Eye of Subjects treated with Lipiflow Thermal Pulsation System'}, {'id': 'OG005', 'title': 'LipiFlow Both Eyes', 'description': 'Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System'}], 'classes': [{'title': 'Change from Baseline to Immediately Post-Treatment', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '1.5', 'groupId': 'OG004'}, {'value': '0.4', 'spread': '1.6', 'groupId': 'OG005'}]}]}, {'title': 'Change from Baseline to Day 1 Post-Treatment', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '1.5', 'groupId': 'OG003'}, {'value': '-1.2', 'spread': '1.9', 'groupId': 'OG004'}, {'value': '-1.1', 'spread': '1.7', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment', 'description': 'Corneal staining was assessed by the examiner using the National Eye Institute corneal grading scale and a slit-lamp. Each of the 5 corneal regions (superior, inferior, central, temporal, \\& central), was graded on a 0-3 scale, where 0=normal-no staining (best); 1=mild-superficial stippling micropunctate staining; 2=moderate-macropunctate staining with some coalescent areas; and 3=severe-numerous coalescent macropunctate areas and/or patches (worst). The scores were summed for each eye, and an overall corneal staining score was computed as the average of the sum from both eyes. Overall scores ranged between 0-15, with higher change value indicating greater damage to the corneal surface. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}, {'value': '69', 'groupId': 'OG005'}]}, {'units': 'Eyes', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}, {'value': '138', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'iLux Right Eye', 'description': 'Right Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG001', 'title': 'iLux Left Eye', 'description': 'Left Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG002', 'title': 'iLux Both Eyes', 'description': 'Both Eyes of Subjects treated with the iLux 2020 System'}, {'id': 'OG003', 'title': 'LipiFlow Right Eye', 'description': 'Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System'}, {'id': 'OG004', 'title': 'LipiFlow Left Eye', 'description': 'Left Eye of Subjects treated with Lipiflow Thermal Pulsation System'}, {'id': 'OG005', 'title': 'LipiFlow Both Eyes', 'description': 'Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '1.54', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '1.49', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '1.94', 'groupId': 'OG003'}, {'value': '-0.04', 'spread': '1.79', 'groupId': 'OG004'}, {'value': '0.01', 'spread': '1.86', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Immediately Post-Treatment (Day 0)', 'description': 'IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A negative change value indicates an improvement. No formal hypothesis testing was pre-specified for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All randomized and treated patients'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '70', 'groupId': 'OG005'}]}, {'units': 'Eyes', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'iLux Right Eye', 'description': 'Right Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG001', 'title': 'iLux Left Eye', 'description': 'Left Eye of Subjects treated with the iLux 2020 System'}, {'id': 'OG002', 'title': 'iLux Both Eyes', 'description': 'Both Eyes of Subjects treated with the iLux 2020 System'}, {'id': 'OG003', 'title': 'LipiFlow Right Eye', 'description': 'Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System'}, {'id': 'OG004', 'title': 'LipiFlow Left Eye', 'description': 'Left Eye of Subjects treated with Lipiflow Thermal Pulsation System'}, {'id': 'OG005', 'title': 'LipiFlow Both Eyes', 'description': 'Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.11', 'groupId': 'OG003'}, {'value': '0.02', 'spread': '0.07', 'groupId': 'OG004'}, {'value': '0.02', 'spread': '0.09', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Immediately Post-Treatment (Day 0)', 'description': 'Visual acuity was assessed with spectacles or other visual corrective devices in place using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Results are presented in logarithm of the minimum angle of resolution (logMAR) with 0.2 in logMAR corresponding to 10 ETDRS letters read. A lower logMAR change value indicates an improvement in visual acuity. No formal hypothesis testing was pre-specified for this endpoint.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All randomized and treated patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'iLux 2020 System', 'description': 'Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual'}, {'id': 'FG001', 'title': 'LipiFlow Thermal Pulsation System', 'description': 'Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Immediately Post-Procedure (Hour 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Day 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Week 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Week 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'iLux 2020 System', 'description': 'Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual'}, {'id': 'BG001', 'title': 'LipiFlow Thermal Pulsation System', 'description': 'Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Under 18 Years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18 Years and Older', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-03', 'size': 1008016, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-22T14:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Meibomian gland score will be assessed by a masked rater'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2017-02-10', 'resultsFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-22', 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 4 in Meibomian Gland Score (MGS)', 'timeFrame': 'Baseline, Week 4', 'description': 'Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator while viewing the eyelid margin using a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3 for a maximum MGS of 45 in each eye. MGS scoring was as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A positive change value indicates an improvement.'}, {'measure': 'Change From Baseline to Week 4 in Tear Break-Up Time (TBT)', 'timeFrame': 'Baseline, Week 4', 'description': "Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBT. A positive change value represents a lengthening in the tear break-up time and greater comfort."}, {'measure': 'Incidence (Number) of Device- or Procedure-related Adverse Events', 'timeFrame': 'Week 4', 'description': 'The number of device- or procedure-related adverse events was calculated, including changes from baseline (Yes/No) in any of the following eyelid characteristics: lid margin assessment or development of floppy eyelids or entropion (eyelid rolled inward) or ectropion (eyelid sagging outward) or loss of lash integrity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)', 'timeFrame': 'Baseline, Week 4', 'description': 'The Ocular Surface Disease Index (OSDI) is a 12-item, patient-reported outcome questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient\'s vision. Each item is scored on a 0-4 Likert-type scale, where 0 is "None" and 4 is "All of the Time." The OSDI is calculated as the (sum of scores) x 25 / (# of questions answered), for a resultant overall score of 0-100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value indicates an improvement.'}, {'measure': 'Mean Pain Score During Treatment', 'timeFrame': 'Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment', 'description': 'The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no pain, 100 = maximum pain) at the point that indicated the pain in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. A score a 20 was associated with a description of "hurts a little". Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.'}, {'measure': 'Mean Discomfort Score During Treatment', 'timeFrame': 'Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment', 'description': 'The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no discomfort, 100 = maximum discomfort) at the point that indicated the discomfort in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.'}, {'measure': 'Change From Baseline to Post-Treatment in Ocular Surface Staining', 'timeFrame': 'Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment', 'description': 'Corneal staining was assessed by the examiner using the National Eye Institute corneal grading scale and a slit-lamp. Each of the 5 corneal regions (superior, inferior, central, temporal, \\& central), was graded on a 0-3 scale, where 0=normal-no staining (best); 1=mild-superficial stippling micropunctate staining; 2=moderate-macropunctate staining with some coalescent areas; and 3=severe-numerous coalescent macropunctate areas and/or patches (worst). The scores were summed for each eye, and an overall corneal staining score was computed as the average of the sum from both eyes. Overall scores ranged between 0-15, with higher change value indicating greater damage to the corneal surface. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.'}, {'measure': 'Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)', 'timeFrame': 'Baseline (Day 0), Immediately Post-Treatment (Day 0)', 'description': 'IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A negative change value indicates an improvement. No formal hypothesis testing was pre-specified for this endpoint.'}, {'measure': 'Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)', 'timeFrame': 'Baseline (Day 0), Immediately Post-Treatment (Day 0)', 'description': 'Visual acuity was assessed with spectacles or other visual corrective devices in place using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Results are presented in logarithm of the minimum angle of resolution (logMAR) with 0.2 in logMAR corresponding to 10 ETDRS letters read. A lower logMAR change value indicates an improvement in visual acuity. No formal hypothesis testing was pre-specified for this endpoint.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['iLux', 'LipiFlow', 'dry eye', 'Meibomian Gland Dysfunction', 'evaporative dry eye'], 'conditions': ['Meibomian Gland Dysfunction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare changes in meibomian gland dysfunction (MGD), tear break-up time (TBT) and evaporative dry eye (EDE) symptoms after treatment with either the iLux® 2020 System or the LipiFlow® Thermal Pulsation System.', 'detailedDescription': 'At the Baseline visit (Day 0), subjects were assessed pre-treatment, during treatment, and post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older of any gender or race\n* Written informed consent to participate in the study\n* Willingness and ability to return for all study visits\n* Positive history of self-reported dry eye symptoms for three months prior to the study using OSDI with a score of ≥ 23 at the baseline visit\n* Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure\n* Tear break-up time \\<10 seconds\n* Agreement/ability to abstain from dry eye/MGD medications for the time between the screening visit and the final study visit (ocular lubricants are allowed if no changes are made during the study)\n\nExclusion Criteria:\n\n* History of ocular or corneal surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year\n* Subjects with giant papillary conjunctivitis\n* Subject with punctal plugs or who have had punctal cautery\n* Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination\n* Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months\n* Subjects who are aphakic\n* Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.\n* Active ocular infection\n* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months\n* Ocular surface abnormality that may compromise corneal integrity\n* Lid surface abnormalities that affect lid function in either eye\n* Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)\n* Systemic disease conditions that cause dry eye\n* Unwillingness to abstain from systemic medications known to cause dryness for the study duration\n* Women who are pregnant, nursing, or not utilizing adequate birth control measures\n* Individuals who have either changed the dosing of systemic medications or non-dry eye/MGD ophthalmic medications within the past 30 days prior to screening\n* Individuals who are unable or unwilling to remain on a stable dosing regimen for the duration of the study\n* Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution 5% (Xiidra) within 3 months, or any other dry eye or MGD medications within 2 weeks of screening (ocular lubricants are allowed if no changes are made during the study)\n* Individuals wearing contact lenses at any time during the prior three months or during the study period\n* Eyelid tattoos, including permanent eyeliner makeup\n* Individuals that were treated with LipiFlow in either eye in the last 24 months\n* Individuals using another ophthalmic investigational device or agent within 30 days of study participation\n* Individuals who are unable to complete the required patient questionnaires in English'}, 'identificationModule': {'nctId': 'NCT03055832', 'briefTitle': 'Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tear Film Innovations, Inc.'}, 'officialTitle': 'Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction', 'orgStudyIdInfo': {'id': '2020-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iLux 2020 System', 'description': 'Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual', 'interventionNames': ['Device: iLux 2020 System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LipiFlow Thermal Pulsation System', 'description': 'Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual', 'interventionNames': ['Device: LipiFlow Pulsation System']}], 'interventions': [{'name': 'iLux 2020 System', 'type': 'DEVICE', 'description': 'Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands', 'armGroupLabels': ['iLux 2020 System']}, {'name': 'LipiFlow Pulsation System', 'type': 'DEVICE', 'description': 'Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content', 'armGroupLabels': ['LipiFlow Thermal Pulsation System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'TearFilm Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'TearFilm Investigative Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92122', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'TearFilm Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'TearFilm 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