Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT06884202
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2025-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Delefilcon A Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in lens movement (overall lens fit) at primary gaze', 'timeFrame': 'Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period', 'description': 'Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens movement (overall lens fit) will be graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable).'}, {'measure': 'Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in lens movement (overall lens fit) at peripheral gazes', 'timeFrame': 'Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period', 'description': 'Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in upward gaze, downward gaze, looking to the left, and looking to the right. Lens movement (overall lens fit) for each gaze will be graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable).'}, {'measure': 'Proportion of lenses graded as Optimal Lens Centration or Acceptable Decentration at Dispense in lens position (centration)', 'timeFrame': 'Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period', 'description': 'Lens position (centration) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens position (centration) will be graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable centration; 2 = Unacceptable decentration.'}, {'measure': 'Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in lens movement (overall fit) at primary gaze', 'timeFrame': 'Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period', 'description': 'Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens movement (overall lens fit) will be graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable).'}, {'measure': 'Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in lens movement (overall fit) at peripheral gazes', 'timeFrame': 'Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period', 'description': 'Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in upward gaze, downward gaze, looking to the left, and looking to the right. Lens movement (overall lens fit) for each gaze will be graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable).'}, {'measure': 'Proportion of lenses graded as Optimal Lens Centration or Acceptable Decentration at 6 Hour Follow-up in lens position (centration)', 'timeFrame': 'Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period', 'description': 'Lens position (centration) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens position (centration) will be graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable centration; 2 = Unacceptable decentration.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact lenses'], 'conditions': ['Refractive Errors', 'Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters.', 'detailedDescription': 'Subjects will be expected to attend 4 office visits for an individual duration of participation of approximately 3 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and a minimum of 6 hours per day during the past 3 months;\n* Able to wear contact lenses within a range of sphere powers from -2.00 and -4.00 diopters (D);\n* Best Corrected Visual Acuity (BCVA) (with manifest refraction) better than or equal to 0.10 logarithm Minimum Angle of Resolution (logMAR ) in each eye.\n\nKey Exclusion Criteria:\n\n* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;\n* History of refractive surgery or plan to have refractive surgery during the study, or irregular cornea in either eye;\n* Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06884202', 'briefTitle': 'Evaluation of Delefilcon A Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of Overall Lens Fit of Delefilcon A Contact Lenses of Different Diameters and Base Curves', 'orgStudyIdInfo': {'id': 'CLU484-P007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'LID023681, then LID006961', 'description': 'Delefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.', 'interventionNames': ['Device: Delefilcon A contact lenses with different base curves and diameters', 'Device: Delefilcon A contact lenses with standard base curves and diameters']}, {'type': 'OTHER', 'label': 'LID006961, then LID023681', 'description': 'Delefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.', 'interventionNames': ['Device: Delefilcon A contact lenses with different base curves and diameters', 'Device: Delefilcon A contact lenses with standard base curves and diameters']}], 'interventions': [{'name': 'Delefilcon A contact lenses with different base curves and diameters', 'type': 'DEVICE', 'otherNames': ['LID023681'], 'description': 'Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.', 'armGroupLabels': ['LID006961, then LID023681', 'LID023681, then LID006961']}, {'name': 'Delefilcon A contact lenses with standard base curves and diameters', 'type': 'DEVICE', 'otherNames': ['DAILIES TOTAL1®', 'LID006961'], 'description': 'Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.', 'armGroupLabels': ['LID006961, then LID023681', 'LID023681, then LID006961']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90013', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kurata Eyecare Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94607', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Elsa Pao, OD', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94127', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Rims Optometry', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'facility': 'Pearson Research Center, PA', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Kindred Optics at Maitland Vision', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '30157', 'city': 'Dallas', 'state': 'Georgia', 'country': 'United States', 'facility': 'Eyeconic Family Eyecare', 'geoPoint': {'lat': 33.92371, 'lon': -84.84077}}, {'zip': '48312', 'city': 'Sterling Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Dr. Schwartz Optometrist and Associates', 'geoPoint': {'lat': 42.58031, 'lon': -83.0302}}, {'zip': '38618', 'city': 'Coldwater', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Coldwater Vision Research', 'geoPoint': {'lat': 32.71486, 'lon': -89.21423}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY College of Optometry Clinical Vision Research Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27502', 'city': 'Apex', 'state': 'North Carolina', 'country': 'United States', 'facility': 'NC Eye Associates, OD, PLLC', 'geoPoint': {'lat': 35.73265, 'lon': -78.85029}}, {'zip': '28278', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'See Eye Care Optometry', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '43023', 'city': 'Granville', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProCare Vision Centers, Inc.', 'geoPoint': {'lat': 40.06812, 'lon': -82.5196}}, {'zip': '43065', 'city': 'Powell', 'state': 'Ohio', 'country': 'United States', 'facility': 'Eyecare Professionals, Inc', 'geoPoint': {'lat': 40.15784, 'lon': -83.07519}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wyomissing Optometric Center', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '02888', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'West Bay Eye Associates', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southern College of Optometry', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Principal Clinical Trial Lead, Vision Care', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}