Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04806802
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2021-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
APIOC Sphere and APIOC Astigmatism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}, {'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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'Day 7', 'description': 'High and Low Contrast LogMAR, Distance'}, {'measure': 'Subjective Vision Quality', 'timeFrame': 'Day 7', 'description': 'Visual analogue scale'}, {'measure': 'Comfort', 'timeFrame': 'Day 7', 'description': 'Visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'Subjective comfort', 'timeFrame': 'Day 7', 'description': 'Compared to habitual lenses'}, {'measure': 'Subjective vision', 'timeFrame': 'Day 7', 'description': 'Compared to habitual lenses'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia', 'Hyperopia', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ Sphere or the APIOC™ Astigmatism contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject must provide written informed consent.\n2. The subject must appear willing and able to adhere to the instructions set forth in this protocol.\n3. At least 18 years of age and no more than 35 years of age.\n4. ≤ 4.00 D (diopters) of corneal astigmatism.\n5. ≤ 2.50 D of refractive astigmatism.\n6. Refractive error range +4.00 DS to -6.00 DS (diopters sphere)\n7. Flat and steep keratometry readings within 40 to 48 D.\n8. Clear, healthy corneas with no irregular astigmatism.\n9. Normal, healthy conjunctiva in both eyes.\n10. Free of active ocular disease. Refractive error is permitted.\n11. Be a current or former (within the last 12 months) contact lens wearer.\n12. Best-corrected near and distance visual acuity better than or equal to 20/25.\n\nExclusion Criteria:\n\n1. Irregular corneal astigmatism.\n2. Presbyopia\n3. Corneal scarring unless off line-of-site and well healed.\n4. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.\n5. Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 drops per week is permitted.\n6. Systemic disease that would interfere with contact lens wear.\n7. Currently pregnant or lactating (by self-report).\n8. History of strabismus or eye movement disorder, including exophoria at near that is 4 D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.\n9. Active allergies that may inhibit contact lens wear.\n10. Upper eyelid margin at or above the superior limbus.\n11. History of ocular or lid surgery.\n12. Immediate family members or significant others of doctors or staff at the clinical site.'}, 'identificationModule': {'nctId': 'NCT04806802', 'briefTitle': 'APIOC Sphere and APIOC Astigmatism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lentechs, LLC'}, 'officialTitle': '7 Day Trial of APIOC Sphere and APIOC Astigmatism', 'orgStudyIdInfo': {'id': 'LEN102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APIOC Sphere or Astigmatism', 'description': 'Single Vision Spherical or Toric Contact Lens', 'interventionNames': ['Device: APIOC Sphere and APIOC Astigmatism']}], 'interventions': [{'name': 'APIOC Sphere and APIOC Astigmatism', 'type': 'DEVICE', 'description': 'Single Vision Contact Lenses', 'armGroupLabels': ['APIOC Sphere or Astigmatism']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Complete Family Vision Care', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Eola Eyes', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '40517', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Gaddie Eye Centers', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '45342', 'city': 'Miamisburg', 'state': 'Ohio', 'country': 'United States', 'facility': 'Miamisburg Vision Care', 'geoPoint': {'lat': 39.64284, 'lon': -84.28661}}, {'zip': '43054', 'city': 'New Albany', 'state': 'Ohio', 'country': 'United States', 'facility': 'Vision Professionals', 'geoPoint': {'lat': 40.08117, 'lon': -82.80879}}, {'zip': '43065', 'city': 'Powell', 'state': 'Ohio', 'country': 'United States', 'facility': 'Eyecare Professionals of Powell', 'geoPoint': {'lat': 40.15784, 'lon': -83.07519}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No sharing of data is planned.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lentechs, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}