Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:49 AM
Study NCT ID:
NCT07303920
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-23', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort', 'timeFrame': 'Measured over 16 hours of wear', 'description': 'Proportion of participants with positive Visual Analog Scale (VAS, \\>50 on a 0-100 scale)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to assess the wear experience of people who have astigmatism when wearing a daily disposable contact lens for astigmatism over long days of wear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current soft toric contact lens wearer with long hours of wear\n* Willing to follow the contact lens wearing schedule required by the study\n* Vision 20/25 or better with current soft toric contact lenses\n* Self-report completion of a comprehensive eye examination in the past two years\n\nExclusion Criteria:\n\n* Have a history of corneal ocular surgery\n* Have current ocular inflammation or infection as assessed by the study investigator who will complete the study\n* Are past rigid contact lens wearers\n* Have a history of being diagnosed with dry eye or ocular allergies\n* Have known systemic health conditions that are thought to alter tear film physiology\n* Have a history of viral eye disease\n* Have a history of ocular surgery\n* Have a history of severe ocular trauma\n* Have a history of corneal dystrophies or degenerations\n* Have active ocular infection or inflammation\n* Are currently using isotretinoin-derivatives or ocular medications\n* Are pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT07303920', 'briefTitle': 'Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day', 'orgStudyIdInfo': {'id': '20252462'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Contact Lens Wear', 'description': 'All participants will be fit with the study contact lenses for astigmatism', 'interventionNames': ['Device: Daily disposable contact lenses for astigmatism']}], 'interventions': [{'name': 'Daily disposable contact lenses for astigmatism', 'type': 'DEVICE', 'otherNames': ['Dailies Total1 for Astigmatism'], 'description': 'All participants will be fit with the study lenses', 'armGroupLabels': ['Contact Lens Wear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma Grant', 'role': 'CONTACT', 'email': 'OPT-EyeStudies@osu.edu', 'phone': '614-292-8858'}, {'name': 'Emily Wagner', 'role': 'CONTACT', 'email': 'OPT-EyeStudies@osu.edu', 'phone': '614-292-8858'}], 'facility': 'The Ohio State University College of Optometry', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Study Coordinators', 'role': 'CONTACT', 'email': 'OPT-EyeStudies@osu.edu', 'phone': '614-292-8858'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer Fogt', 'investigatorAffiliation': 'Ohio State University'}}}}