Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-01-02 @ 10:29 AM
Study NCT ID:
NCT06329661
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in corneal ECD', 'timeFrame': '12 months', 'description': 'ECD measured as count/mm2 using specular microscopy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)', 'detailedDescription': 'The effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell density (cells/mm²) will be evaluated in comparison to a hypotonic saline solution in subjects with DED after 12 months of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be at least 18 years of age;\n* Provide written informed consent;\n* Have a subject reported history of dry eye disease (DED) in both eyes\n* Be able and willing to follow instructions, including participation in all trial assessments and visits.\n\nExclusion Criteria:\n\n* Be a woman who is pregnant, nursing, or planning a pregnancy;\n* Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control\n* Clinically significant slit-lamp findings or abnormal lid anatomy at screening\n* Ocular/periocular malignancy\n* History of herpetic keratitis\n* Have any primary or secondary corneal endothelial disorder such as Fuchs dystrophy or other endothelial dystrophy, significant guttata\n* Ongoing ocular or systemic infection at screening or baseline\n* Presence of uncontrolled systemic diseases\n* Presence of known allergy and/or sensitivity to the study drug or its components\n* Intraocular surgery or ocular laser surgery or significant trauma within 365 days before Visit 1, or have any planned ocular surgeries during the trial period;\n* Have a known allergy or sensitivity to the IMP or its components\n* Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the trial results, or may interfere with the subject's participation in the trial significantly.\n* Randomized in a previous CyclASol trial"}, 'identificationModule': {'nctId': 'NCT06329661', 'briefTitle': 'A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novaliq GmbH'}, 'officialTitle': 'A Multi-center, Randomized, Double-masked, Controlled Clinical Trial to Evaluate the Corneal Endothelial Health of Dry Eye Disease Subjects Treated With Cyclosporine Ophthalmic Solution, 0.1%', 'orgStudyIdInfo': {'id': 'CYS-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclosporine ophthalmic solution, 0.1% (VEVYE)', 'description': 'Cyclosporine ophthalmic solution, 0.1%; 12 months', 'interventionNames': ['Drug: Cyclosporine ophthalmic solution, 0.1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline solution, 0.6%', 'description': 'Saline solution, 0.6%; 12 months', 'interventionNames': ['Drug: Saline solution, 0.6%']}], 'interventions': [{'name': 'Cyclosporine ophthalmic solution, 0.1%', 'type': 'DRUG', 'otherNames': ['VEVYE'], 'description': 'Colorless and clear opthalmic solution containing 0.1% Cyclosporine', 'armGroupLabels': ['Cyclosporine ophthalmic solution, 0.1% (VEVYE)']}, {'name': 'Saline solution, 0.6%', 'type': 'DRUG', 'description': 'Colorless and clear sodium chloride solution (0.6%)', 'armGroupLabels': ['Saline solution, 0.6%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'CYS-007 Investigational Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'CYS-007 Investigational Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '27529', 'city': 'Garner', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CYS-007 Investigational Site', 'geoPoint': {'lat': 35.71126, 'lon': -78.61417}}, {'zip': '28150', 'city': 'Shelby', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CYS-007 Investigational Site', 'geoPoint': {'lat': 35.29235, 'lon': -81.53565}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CYS-007 Investigational Site', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'CYS-007 Investigational Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Sonja Krösser, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novaliq GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novaliq GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}