Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01294956
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2011-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065346', 'term': 'Lubricant Eye Drops'}, {'id': 'D002266', 'term': 'Carboxymethylcellulose Sodium'}], 'ancestors': [{'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D054327', 'term': 'Lubricants'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D008747', 'term': 'Methylcellulose'}, {'id': 'D002482', 'term': 'Cellulose'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-17', 'studyFirstSubmitDate': '2011-02-10', 'studyFirstSubmitQcDate': '2011-02-11', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Staining', 'timeFrame': 'Day 42'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry eye', 'artificial tears', 'corneal staining'], 'conditions': ['Dry Eye']}, 'referencesModule': {'references': [{'pmid': '24403819', 'type': 'RESULT', 'citation': 'Cohen S, Martin A, Sall K. Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose. Clin Ophthalmol. 2014;8:157-64. doi: 10.2147/OPTH.S53822. Epub 2013 Dec 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of dry eye\n* NaFl Corneal staining sum score ≥ 3 in either eye\n* Current use of a lubricant eye gel or ointment at least once per week (over the previous month)\n\nExclusion Criteria:\n\n* No contact lenses wear throughout the study period\n* Must not have had punctal plugs inserted within 30 days preceding enrollment'}, 'identificationModule': {'nctId': 'NCT01294956', 'briefTitle': 'A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-10-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FID 115958D', 'description': 'Lubricant Eye Drop', 'interventionNames': ['Other: Lubricant Eye Drop']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Refresh Liquigel', 'description': 'Lubricant Eye Drop', 'interventionNames': ['Other: Refresh Liquigel']}], 'interventions': [{'name': 'Lubricant Eye Drop', 'type': 'OTHER', 'description': '1 drop in each eye, four times a day for 42 days', 'armGroupLabels': ['FID 115958D']}, {'name': 'Refresh Liquigel', 'type': 'OTHER', 'description': '1 drop in each eye, four times a day for 42 days', 'armGroupLabels': ['Refresh Liquigel']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}