Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-26 @ 12:38 PM
Study NCT ID:
NCT07284966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comfort and Vision With TOTAL30 Multifocal Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Contact Lens Dry Eye Questionnaire (CLDEQ-8)', 'timeFrame': 'After 1 month of wear', 'description': 'A series of 8 questions that ask participants to rate eye discomfort, eye dryness, and blurry vision on a frequency scale (0 Never, 1 Rarely, 2 Sometimes, 3 Frequently, 4 Constantly) and an intensity scale (0 Never, 1 not intense to 5 Very Intense). Scores on individual questions are added together to determine a total score. Higher values indicate worse outcomes. The minimum score is 1 and the maximum score is 37.'}, {'measure': 'Distance Visual Acuity', 'timeFrame': 'After 1 month of wear'}, {'measure': 'Near Visual Acuity', 'timeFrame': 'After 1 month of wear'}], 'primaryOutcomes': [{'measure': 'Patient-reported comfort level of the TOTAL30 Multifocal Lens', 'timeFrame': '16 hours of wear on specified days over a 30-day period', 'description': 'Comfort level assessed using real-time patient-reported data collected at multiple time points throughout the day, with a focus on the end of the wear period. Patients are asked "What is your impression of the COMFORT of these study lenses?" and provide and answer from -50 (Extremely uncomfortable) to +50 (Extremely comfortable) using a sliding digital scale.'}], 'secondaryOutcomes': [{'measure': 'Patient-reported vision quality with the TOTAL30 Multifocal Lens', 'timeFrame': '16 hours of wear on specified days over a 30-day period', 'description': 'Vision quality assessed using real-time patient-reported data collected at various time points during the day. Patients are asked "What is your impression of the VISION quality of these study lenses?" and provide and answer from -50 (Poor quality) to +50 (Excellent quality) using a sliding digital scale.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia', 'Presbyopia', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'This study is a single-arm, prospective, observational study conducted at one site to evaluate the comfort and vision of the TOTAL30 Multifocal (T30MF) contact lenses over the course of long wear days. The study will assess the proportion of positive subjective Visual Analog Scale (VAS) assessments of comfort and vision at 10, 12, 14, and 16 hours of wear on Days 1, 7, 14, and 30. Additionally, the study will explore subjective assessments of lens comfort using the CLDEQ-8 survey and measure logMAR visual acuity at both distance and near at Visit 1, Visit 2, and after 1 month of lens wear. Participants will undergo three site visits, with at-home surveys conducted at specified intervals to gather real-time data on comfort and vision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged 40 years or older who currently wear soft multi-focal contact lenses.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects are eligible for the study if they meet the following criteria:\n\n* Subjects who currently wear soft multi-focal contact lenses and score \\<12 on an entering CLDEQ-8 survey.\n* Subjects who are \\>= 40 years old.\n* Subjects who can and are willing to wear their lenses for 13 hours per day during the study period, and 16 hours per day when questionnaires are being taken.\n* Willing to insert their contact lenses between 6:00 am and 8:00 am on the days when questionnaires will be taken.\n* Vision correctable in soft multi-focal contact lenses to 20/25 (0.10 log MAR) or better in each eye at 6M.\n* Must be able to be successfully fit into the prescription parameters available for Total30 MF contact lenses.\n* Required to have a smartphone and receive push notifications.\n* Willing to attend all study visits.\n* Willing to be diligent about answering the timed surveys in a prompt manner.\n\nExclusion Criteria:\n\nIf any of the following exclusion criteria are applicable, the subject should not be enrolled in the study.\n\n* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.\n* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator.\n* Use of isotretinoin-derivatives.\n* Use of lubricating drops.\n* Monocular patients or patients fit with only 1 multifocal lens.\n* Prior refractive surgery.\n* History of herpetic keratitis, ocular surgery, or irregular cornea.\n* Pregnant or lactating.\n* Having participated in a clinical trial in the past 30 days.\n* High-ADD habitual wearers using a different fitting approach than Alcon's multifocal fitting guide (e.g., J\\&J or CooperVision's fitting guide adopting a modified monovision approach).\n* Are past rigid CL wearers.\n* Have a history of being diagnosed with dry eye or ocular allergies.\n* Have history of severe ocular trauma."}, 'identificationModule': {'nctId': 'NCT07284966', 'briefTitle': 'Comfort and Vision With TOTAL30 Multifocal Lenses', 'organization': {'class': 'OTHER', 'fullName': 'Scripps Poway Eyecare and Optometry'}, 'officialTitle': 'Evaluation of Wear Comfort and Vision With Total 30 Multifocal Lenses Over 16 Hours of Wear', 'orgStudyIdInfo': {'id': 'JM-25-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TOTAL30 Multifocal', 'type': 'DEVICE', 'description': 'TOTAL30 Multifocal'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92131', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Amy Minshall', 'role': 'CONTACT', 'email': 'amylminshall@gmail.com', 'phone': '858-530-2800'}, {'name': 'Jay Mashouf, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Scripps Optometric Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Amy Minshall', 'role': 'CONTACT', 'email': 'amylminshall@gmail.com', 'phone': '858-530-2800'}], 'overallOfficials': [{'name': 'Jay Mashouf, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Optometric Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scripps Poway Eyecare and Optometry', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sengi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}