Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT02617095
Status:
TERMINATED
Last Update Posted:
2017-03-08
First Post:
2015-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'recruitment rate too slow', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2015-11-26', 'studyFirstSubmitQcDate': '2015-11-26', 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the symptomatology evaluation on a Visual Analogic Scale', 'timeFrame': 'Day 28'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in the treatment of moderate to severe Dry Eye Syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated informed consent.\n* Male or female aged ≥ 18 years old.\n* Diagnosis of moderate to severe dry eye syndrome\n\nExclusion Criteria:\n\n* Pregnancy, lactation.\n* Childbearing potential woman who is not using a reliable method of contraception and is not surgically sterilised.\n* Inability of patient to understand the study procedures and thus inability to give informed consent.\n* Non-compliant patient\n* Participation in another clinical study at the same time as the present study.\n* Participation to the present study during the exclusion period of another clinical study.\n* Already included once in this study.\n* Ward of court.\n* Patient not covered by government health care scheme'}, 'identificationModule': {'nctId': 'NCT02617095', 'briefTitle': 'Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome', 'orgStudyIdInfo': {'id': 'LT2762-PIV-11/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T2762', 'description': 'One drop of T2762 in each eye 3 to 6 times daily', 'interventionNames': ['Device: T2762']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Optive', 'description': 'One drop of Optive in each eye 3 to 6 times daily', 'interventionNames': ['Device: Optive']}], 'interventions': [{'name': 'T2762', 'type': 'DEVICE', 'description': 'One drop in each eye 3 to 6 times daily', 'armGroupLabels': ['T2762']}, {'name': 'Optive', 'type': 'DEVICE', 'description': 'One drop in each eye 3 to 6 times daily', 'armGroupLabels': ['Optive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Laboratoires Théa', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Frank Larkin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moorfields Eye Hospital -162 city road - London'}, {'name': 'Friedrich KRUSE, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augenklinik mit Poliklinik - Swabachanlage 6 - 91054 Erlangen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}