Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-04-14 @ 11:51 AM
Study NCT ID:
NCT01104961
Status:
WITHDRAWN
Last Update Posted:
2018-08-17
First Post:
2010-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying the Relationship Between Contact Lens Packaging Solutions and Bacterial Binding to Surface Eye Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003320', 'term': 'Corneal Ulcer'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000028', 'term': 'Abortion, Induced'}], 'ancestors': [{'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Other projects took precedence, no mechanism of funding establed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2010-04-09', 'studyFirstSubmitQcDate': '2010-04-14', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial binding of Pseudomonas Aeruginosa', 'timeFrame': '5 weeks', 'description': 'Counting the number of bacteria that bind to surface epithelial cells.'}]}, 'conditionsModule': {'keywords': ['Bacterial infection', 'Loss of epithelial cells'], 'conditions': ['Corneal Ulcer']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to investigate the overall theory that the use of chemically preserved solutions associated with contact lenses promotes an increase in bacterial infection.', 'detailedDescription': 'The purpose of this study is to investigate the theory of bacterial binding to surface eye cells through the use of chemically preserved solutions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range: 18-38 years\n* Any sex, race or national origin accepted as with our past studies. Minority representation will be proactively encouraged.\n* No prior history of any contact lens wear within one month of entry into the study.\n* No history of allergic eye disease either seasonal or associated with previous contact lens wear.\n\nExclusion Criteria:\n\n* Any patient that is a current contact lens wearer.\n* Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, glaucoma, etc.\n* Uncontrolled systemic disease or the presence of any significant illness or condition that could, in the judgment of the investigator, interfere with interpretation of the study results.\n* Any patient using ocular tears, anti-histamine based ocular therapies, glaucoma therapy, vasoconstricting drops, etc.'}, 'identificationModule': {'nctId': 'NCT01104961', 'briefTitle': 'Studying the Relationship Between Contact Lens Packaging Solutions and Bacterial Binding to Surface Eye Cells', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'A Masked, Randomized, Prospective, Single Center Crossover Clinical Trial on the Relationship Between Chemically Preserved Contact Lens Packaging Solutions and Bacterial Binding to Corneal Epithelial Cells', 'orgStudyIdInfo': {'id': '032010-081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contact Lens Packaging Solution #1', 'description': 'Test solution - contact lens packaging solution', 'interventionNames': ['Device: Contact lens packaging solution']}, {'type': 'EXPERIMENTAL', 'label': 'Contact lens packaging solution #2', 'description': 'Test solution - contact lens packaging solution', 'interventionNames': ['Device: Contact lens packaging solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Balanced salt solution', 'description': 'Control solution', 'interventionNames': ['Device: Balanced salt solution (BSS)']}], 'interventions': [{'name': 'Contact lens packaging solution', 'type': 'DEVICE', 'otherNames': ['Blister pack solution'], 'description': 'These test solutions are the intervention being tested.', 'armGroupLabels': ['Contact Lens Packaging Solution #1', 'Contact lens packaging solution #2']}, {'name': 'Balanced salt solution (BSS)', 'type': 'DEVICE', 'otherNames': ['Saline solution'], 'description': 'BSS is isotonic to the tissues of the eyes.', 'armGroupLabels': ['Balanced salt solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Danielle Robertson, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Danielle Robertson', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}