Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 10:44 PM
Study NCT ID:
NCT01446835
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2011-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2011-10-03', 'studyFirstSubmitQcDate': '2011-10-03', 'lastUpdatePostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cosmetic Appearance Preference', 'timeFrame': 'After 20 minutes of wear', 'description': 'Participant will be asked on a questionnaire, "Which lens do you prefer for looking more natural?" Subject will record on the questionnaire, "Left lens," "Right lens," or "No preference."'}], 'secondaryOutcomes': [{'measure': 'Lens Centration', 'timeFrame': 'After insertion and before 20 minutes of wear', 'description': "Investigator will assess lens centration using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens centration will be graded on a 5-point scale, with 0 being centered and 4 being severe decentration with corneal exposure."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cosmetic Appearance']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the cosmetic appearance of two different contact lenses on Asian eyes.', 'detailedDescription': 'Participants will be asked to evaluate the cosmetic appearance of two different contact lenses worn contralaterally for 20 minutes. No vision or comfort variables will be assessed in this cosmetic appearance and lens fit non-dispensing study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female between 18 and 30 years of age (inclusive).\n* If under 21 years of age, subject must sign informed assent and have written consent of parent or guardian to participate.\n* Sign written Informed Consent.\n* Chinese, Japanese, or Korean descent.\n* Brown eye color.\n* Spherical equivalent refractive error of -0.50 diopter (D) and between (-1.50 to -2.50D), (-3.50 to -4.50D) and (-5.50 to -6.50D).\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Eye injury or surgery within twelve weeks prior to enrollment.\n* Pre-existing ocular irritation that would preclude contact lens fitting.\n* Currently enrolled in any clinical ophthalmic trial.\n* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.\n* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01446835', 'briefTitle': 'Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'P-418-C-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nelfilcon A', 'description': 'Nelfilcon A printed contact lens randomly assigned to one eye, with etafilcon A printed contact lens assigned to the fellow eye for contralateral wear. Lenses will be worn for 20 minutes.', 'interventionNames': ['Device: nelfilcon A contact lens with print']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'etafilcon A', 'description': 'Etafilcon A printed contact lens randomly assigned to one eye, with nelfilcon A printed contact lens assigned to the fellow eye for contralateral wear.', 'interventionNames': ['Device: etafilcon A contact lens with print']}], 'interventions': [{'name': 'nelfilcon A contact lens with print', 'type': 'DEVICE', 'description': 'Investigational spherical contact lens', 'armGroupLabels': ['nelfilcon A']}, {'name': 'etafilcon A contact lens with print', 'type': 'DEVICE', 'otherNames': ['1-DAY ACUVUE DEFINE Vivid Style'], 'description': 'Commercially marketed (Singapore) spherical contact lens', 'armGroupLabels': ['etafilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '139651', 'city': 'Spoc', 'state': 'W115', 'country': 'Singapore', 'facility': 'Singapore Polytechnic'}], 'overallOfficials': [{'name': 'Danny Sim Chek Hoo, B Optom (Hons)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singapore Polytechnic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}