Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-28 @ 8:40 PM
Study NCT ID:
NCT01898260
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2013-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-08', 'studyFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2013-07-10', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial Comfort', 'timeFrame': 'Baseline', 'description': 'Initial Comfort will be assessed bilaterally by the participant at time of dispense. Initial Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).'}], 'secondaryOutcomes': [{'measure': 'End of Day Comfort', 'timeFrame': 'Day 7', 'description': 'End of Day Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. End of Day Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).'}, {'measure': 'Overall Comfort', 'timeFrame': 'Day 7', 'description': 'Overall Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).'}, {'measure': 'Overall Handling at Time of Removal', 'timeFrame': 'Day 7', 'description': 'Overall Handling at Time of Removal will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Handling at Time of Removal will be graded on a 1-10 scale (10=excellent, very easy; 1=unmanageable).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contact lenses', 'daily disposable contact lenses', 'silicone hydrogel', 'contact lens comfort', 'near-sighted'], 'conditions': ['Myopia', 'Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adapted soft contact lens wearer;\n* Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);\n* Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;\n* Correctable to 6/9 (20/30) in both eyes;\n* Read, understood and signed the informed consent;\n* Willing to comply with the wear schedule;\n* Willing to comply with the study visit schedule;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any active corneal infection, injury or inflammation;\n* Systemic or ocular allergies which might interfere with contact lens wear;\n* Systemic or ocular disease which might interfere with contact lens wear;\n* Strabismus or amblyopia;\n* Corneal refractive surgery and any anterior segment surgery;\n* Use of systemic/topical medication contraindicating contact lens wear;\n* Use of gas permeable contact lenses within 1 month preceding the study;\n* Participation in any concurrent clinical trial or in the last 30 days;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01898260', 'briefTitle': 'Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses', 'orgStudyIdInfo': {'id': 'C-13-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BYO Daily, then MyDay', 'description': 'Ultrafilcon B contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 1 week in a daily wear, daily disposable modality.', 'interventionNames': ['Device: Ultrafilcon B contact lens', 'Device: Stenfilcon A contact lens']}, {'type': 'OTHER', 'label': 'MyDay, then BYO Daily', 'description': 'Stenfilcon A contact lenses, followed by ultrafilcon B contact lenses. Each product worn bilaterally for 1 week in a daily wear, daily disposable modality.', 'interventionNames': ['Device: Ultrafilcon B contact lens', 'Device: Stenfilcon A contact lens']}], 'interventions': [{'name': 'Ultrafilcon B contact lens', 'type': 'DEVICE', 'otherNames': ['Procornea BYO™ Air Daily'], 'description': 'Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.', 'armGroupLabels': ['BYO Daily, then MyDay', 'MyDay, then BYO Daily']}, {'name': 'Stenfilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['MyDay™ Daily Disposable'], 'description': 'Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.', 'armGroupLabels': ['BYO Daily, then MyDay', 'MyDay, then BYO Daily']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Surrey', 'country': 'United Kingdom', 'facility': 'Alcon Investigative Site'}], 'overallOfficials': [{'name': 'Joachim Nick, Dipl. Ing.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}