Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05624320
Status:
WITHDRAWN
Last Update Posted:
2024-04-09
First Post:
2022-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of interest', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint will be changes from baseline in letters read at near without loss of distance acuity (defined as loss of 5 or more letters)', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'secondary endpoint will be changes in intermediate letters read from baseline', 'timeFrame': '30 days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['presbyopia'], 'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'AGN-190584 has gone through many clinical trials showing its safety and effectiveness in individuals from 40-55 years of age. There has been no published data on the use of this product in individuals corrected with contact lenses for distance vision. There are many other applications AGN-190584 could be used for and further studies will show the effectiveness for each.', 'detailedDescription': 'The study is a single center open label, single arm study with no control and no randomization. Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator. Investigators will measure change in letters read at near and intermediate vision from baseline. Subjects will be required to apply AGN-190584 drops once daily OU. Subjects will be applying the drops on their own every day including the day of visits. During treatment investigators will measure changes in letters read from baseline in intermediate and near vision at the days 7, 14 and 21. These visits will be conducted between 2 and 4 hours after instillation of AGN-190584, with 3 hours being the target time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects from age 40-55\n* Prescription range: -4.00 - +1.00\n* Correctable to 20/25 or better for distance\n* Adapted single use contact lens patients\n* Subjects able to understand the consent agreement and willing to participate\n\nExclusion Criteria:\n\n* Non-contact lens wearer\n* Previous use of AGN-190584\n* Out of age range\n* Out of prescription range\n* Any corneal abnormality\n* Any eye pathology\n* Iritis\n* Know allergy to pilocarpine'}, 'identificationModule': {'nctId': 'NCT05624320', 'briefTitle': 'Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses', 'organization': {'class': 'OTHER', 'fullName': 'Gordon Schanzlin New Vision'}, 'officialTitle': 'Improved Near Vision and Intermediate Without Loss of Binocular Distance Vision Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses for Distance Vision Correction in Both Eyes', 'orgStudyIdInfo': {'id': 'Gordon Schanzlin New Vision'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single center open label, single arm study with no control and no randomization', 'description': 'Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator', 'interventionNames': ['Drug: AGN-190584']}], 'interventions': [{'name': 'AGN-190584', 'type': 'DRUG', 'description': 'miotic for treatment of presbyopia', 'armGroupLabels': ['single center open label, single arm study with no control and no randomization']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gordon Schanzlin New Vision', 'class': 'OTHER'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}