Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT03616600
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2018-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety and Effectiveness of Breath-O Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'henryhl.chan@polyu.edu.hk', 'phone': '+85227667937', 'title': 'Dr. Henry Chan', 'organization': 'Hong Kong Polytechnic University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Wearing the orthokeratology lenses for 3 months\n\nBreath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Not wearing any contact lenses', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'poor visual quality', 'notes': 'symptoms like glare and reduction in contrast from orthokeratology wearing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3.33'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Group randomly selected to wear the Breath-O Correct lenses\n\nBreath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material'}, {'id': 'OG001', 'title': 'Control', 'description': 'Group randomly selected not to wear any contact lenses'}], 'classes': [{'title': 'Corneal Hysteresis_Baseline', 'categories': [{'measurements': [{'value': '11.12', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '11.10', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Hysteresis_1st Month', 'categories': [{'measurements': [{'value': '10.37', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '11.20', 'spread': '1.89', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Hysteresis_3rd Month', 'categories': [{'measurements': [{'value': '10.14', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '11.19', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Resistance Factor_Baseline', 'categories': [{'measurements': [{'value': '11.07', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '11.14', 'spread': '2.23', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Resistance Factor_1st Month', 'categories': [{'measurements': [{'value': '9.87', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '10.92', 'spread': '2.45', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Resistance Factor_3rd Month', 'categories': [{'measurements': [{'value': '9.99', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '10.79', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1st Month, 3rd Month', 'description': 'measured by ocular response analyser', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Endothelial Health in Terms of Endothelial Cell Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Group randomly selected to wear the Breath-O Correct lenses\n\nBreath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material'}, {'id': 'OG001', 'title': 'Control', 'description': 'Group randomly selected not to wear any contact lenses'}], 'classes': [{'title': 'Corneal Endothelial Cell Density_Baseline', 'categories': [{'measurements': [{'value': '2909', 'spread': '145.1', 'groupId': 'OG000'}, {'value': '2861', 'spread': '181.05', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Endothelial Cell Density_1st month', 'categories': [{'measurements': [{'value': '2923', 'spread': '123.01', 'groupId': 'OG000'}, {'value': '2818', 'spread': '182.65', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Endothelial Cell Density_3rd month', 'categories': [{'measurements': [{'value': '2917', 'spread': '157.34', 'groupId': 'OG000'}, {'value': '2825', 'spread': '177.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1st Month, 3rd Month', 'description': 'measured by specular microscope', 'unitOfMeasure': 'cell/mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Corrected Visual Acuity in Terms of High and Low Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Group randomly selected to wear the Breath-O Correct lenses'}], 'classes': [{'title': 'High contrast VA_Baseline', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'High contrast VA_1st Month', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': 'High contrast VA_3rd Month', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': 'Low contrast VA_Basline', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': 'Low contrast VA_1st Month', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.14', 'groupId': 'OG000'}]}]}, {'title': 'Low contrast VA_3rd Month', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1st Month and the 3rd Month', 'description': 'The best corrected visual acuity was measured in LogMAR (Snellen 20/20 vision = 0.00 in LogMAR ; each readable letter add -0.02 to the score, the smaller the number i.e. more negative, the better visual acuity)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It is a comparison of visual performance before-and-after treatment and therefore only the best corrected visual acuity in treatment group in different time points were compared.'}, {'type': 'SECONDARY', 'title': 'Reduction of the Refractive Power After Wearing the Breath-O-correct Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Group randomly selected to wear the Breath-O Correct lenses\n\nBreath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material'}], 'classes': [{'title': 'Refractive errors_Baseline', 'categories': [{'measurements': [{'value': '-3.52', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Refractive errors_1st Week', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Refractive errors_1st Month', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'Refractive errors_3rd Month', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1st Week, 1st Month, 3rd Month', 'description': 'Refractive errors were determined by subjective refraction for treatment group (Breath-O correct lens wearer), the outcome was represented as mean spherical equivalent refraction with unit in diopter (SER, = 1/2 Cylindrical power + spherical power)', 'unitOfMeasure': 'Diopter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It is a comparison of refractive errors before-and-after treatment and therefore only the refractive errors in treatment group in different time points were compared.'}, {'type': 'PRIMARY', 'title': 'Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Group randomly selected to wear the Breath-O Correct lenses\n\nBreath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material'}, {'id': 'OG001', 'title': 'Control', 'description': 'Group randomly selected not to wear any contact lenses'}], 'classes': [{'title': 'Corneal Endothelial Cell Variance_Baseline', 'categories': [{'measurements': [{'value': '28.68', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '29.35', 'spread': '3.66', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Endothelial Cell Variance_1st month', 'categories': [{'measurements': [{'value': '28.47', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '29.00', 'spread': '3.58', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Endothelial Cell Variance_3rd month', 'categories': [{'measurements': [{'value': '29.00', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '30.01', 'spread': '3.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1st Month, 3rd Month', 'description': 'measured by specular microscope', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Ocular Health in Terms of Limbal and Bulbar Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Group randomly selected to wear the Breath-O Correct lenses\n\nBreath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material'}, {'id': 'OG001', 'title': 'Control', 'description': 'Group randomly selected not to wear any contact lenses'}], 'classes': [{'title': 'Bulbar redness_Baseline', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Bulbar redness_1st Month', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Bulbar redness_3rd Month', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Limbal redness_Baseline', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Limbal redness_1st Month', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Limbal redness_3rd Month', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1st Month, 3rd Month', 'description': 'measured by OCULUS Keratograph® 5M and graded by JENVIS redness grading system It is a scale of 0 to 4, the higher the score, the more redness the ocular surface manifests', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Group randomly selected to wear the Breath-O Correct lenses\n\nBreath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material'}, {'id': 'OG001', 'title': 'Control', 'description': 'Group randomly selected not to wear any contact lenses'}], 'classes': [{'title': 'NIKBUT_1st break_Baseline', 'categories': [{'measurements': [{'value': '6.72', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '9.92', 'spread': '6.76', 'groupId': 'OG001'}]}]}, {'title': 'NIKBUT_1st break_1st Month', 'categories': [{'measurements': [{'value': '9.13', 'spread': '5.45', 'groupId': 'OG000'}, {'value': '9.17', 'spread': '5.63', 'groupId': 'OG001'}]}]}, {'title': 'NIKBUT_1st break_3rd Month', 'categories': [{'measurements': [{'value': '9.83', 'spread': '6.37', 'groupId': 'OG000'}, {'value': '7.64', 'spread': '4.97', 'groupId': 'OG001'}]}]}, {'title': 'NIKBUT_average_Baseline', 'categories': [{'measurements': [{'value': '10.94', 'spread': '4.15', 'groupId': 'OG000'}, {'value': '13.24', 'spread': '6.56', 'groupId': 'OG001'}]}]}, {'title': 'NIKBUT_average_1st Month', 'categories': [{'measurements': [{'value': '12.42', 'spread': '5.73', 'groupId': 'OG000'}, {'value': '11.86', 'spread': '5.99', 'groupId': 'OG001'}]}]}, {'title': 'NIKBUT_average_3rd Month', 'categories': [{'measurements': [{'value': '12.07', 'spread': '6.76', 'groupId': 'OG000'}, {'value': '9.57', 'spread': '5.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1st Month, 3rd Month', 'description': 'measured by OCULUS Keratograph® 5M', 'unitOfMeasure': 'Second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Wearing the orthokeratology lenses for 3 months\n\nBreath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material'}, {'id': 'FG001', 'title': 'Control', 'description': 'Not wearing any contact lenses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'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'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Wearing the orthokeratology lenses for 3 months\n\nBreath-O-Correct Lens: Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material'}, {'id': 'BG001', 'title': 'Control', 'description': 'Not wearing any contact lenses'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19.8', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '22.2', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '21.1', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Refractive errors', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-3.47', 'spread': '1.01', 'groupId': 'BG000'}, {'value': '-3.71', 'spread': '1.76', 'groupId': 'BG001'}, {'value': '-3.61', 'spread': '1.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Diopters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-10', 'size': 82361, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-26T23:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2018-03-15', 'resultsFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2018-08-03', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-31', 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor', 'timeFrame': 'Baseline, 1st Month, 3rd Month', 'description': 'measured by ocular response analyser'}, {'measure': 'Corneal Endothelial Health in Terms of Endothelial Cell Density', 'timeFrame': 'Baseline, 1st Month, 3rd Month', 'description': 'measured by specular microscope'}, {'measure': 'Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size', 'timeFrame': 'Baseline, 1st Month, 3rd Month', 'description': 'measured by specular microscope'}, {'measure': 'Anterior Ocular Health in Terms of Limbal and Bulbar Redness', 'timeFrame': 'Baseline, 1st Month, 3rd Month', 'description': 'measured by OCULUS Keratograph® 5M and graded by JENVIS redness grading system It is a scale of 0 to 4, the higher the score, the more redness the ocular surface manifests'}, {'measure': 'Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)', 'timeFrame': 'Baseline, 1st Month, 3rd Month', 'description': 'measured by OCULUS Keratograph® 5M'}], 'secondaryOutcomes': [{'measure': 'Best Corrected Visual Acuity in Terms of High and Low Contrast', 'timeFrame': 'Baseline, 1st Month and the 3rd Month', 'description': 'The best corrected visual acuity was measured in LogMAR (Snellen 20/20 vision = 0.00 in LogMAR ; each readable letter add -0.02 to the score, the smaller the number i.e. more negative, the better visual acuity)'}, {'measure': 'Reduction of the Refractive Power After Wearing the Breath-O-correct Lens', 'timeFrame': 'Baseline, 1st Week, 1st Month, 3rd Month', 'description': 'Refractive errors were determined by subjective refraction for treatment group (Breath-O correct lens wearer), the outcome was represented as mean spherical equivalent refraction with unit in diopter (SER, = 1/2 Cylindrical power + spherical power)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myopia', 'Orthokeratology'], 'conditions': ['Myopia', 'Safety Issues']}, 'descriptionModule': {'briefSummary': 'In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression. One of the most successful treatments for myopia is orthokeratology. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.', 'detailedDescription': 'Short-sightedness (myopia) is the most common refractive error in the world. In Hong Kong, approximately 80% of children are myopic by the end of childhood. Current treatment strategies to control (i.e. slow) myopia progression in children are primarily designed to harness the natural "emmetropization" process, in which visual feedback from retinal image clarity regulates the rate of eye growth. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression, not least since this approach permits clear central vision. One of the most successful treatments for myopia is orthokeratology, which is a therapy of using custom-made rigid gas permeable contact lens. The special design of this contact lens can reshape the corneal profile to minimize the central refractive error while producing beneficial peripheral defocus. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Refractive error: Spherical: normally -1.00D to -4.00D (maximum up to -5.00D); Cylindrical: normally half of Sph (against-the-rule Astigmatism.: lower than -0.75D) (maximum up to -1.50D)\n2. Best corrected Visual acuity: monocular ETDRS 0.0 or better\n3. Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery\n4. General health: No systemic diseases\n5. Requirement: No history of orthokeratology lens wearing. Agree to participate in this study and willing to wear the orthokeratology lenses overnight in accordance with the instructions given and to come back for follow up within the study period'}, 'identificationModule': {'nctId': 'NCT03616600', 'briefTitle': 'The Safety and Effectiveness of Breath-O Lenses', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses', 'orgStudyIdInfo': {'id': 'HongKongPU_Optometry2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Wearing the orthokeratology lenses for 3 months', 'interventionNames': ['Other: Breath-O-Correct Lens']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Not wearing any contact lenses'}], 'interventions': [{'name': 'Breath-O-Correct Lens', 'type': 'OTHER', 'description': 'Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'SEED Co. Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assocaite Professor', 'investigatorFullName': 'Henry HL Chan, PhD', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}