Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT00851734
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2009-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}], 'ancestors': [{'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2009-02-24', 'studyFirstSubmitQcDate': '2009-02-25', 'lastUpdatePostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ocular irritation', 'timeFrame': '12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Keratoconjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG\n* Schirmer's I Test ≥ 10mm/5 minutes with anesthesia\n* Corrected Snellen acuity of 20/40 or better in both eyes\n\nExclusion Criteria:\n\n* Subjects diagnosed with any ocular disease other than refraction error\n* Subjects with intraocular pressure \\>21 mmHg\n* Use of a contact lens within 7 days prior to administration of the first dose\n* Subjects with history of ocular surgery\n* Subjects with a history of laser refractive surgery"}, 'identificationModule': {'nctId': 'NCT00851734', 'briefTitle': 'A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lux Biosciences, Inc.'}, 'officialTitle': 'A Phase 1 Dose-Escalation Study To Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed By an Open-Label Evaluation of LX214 Ophthalmic Solution in Patients With Keratoconjunctivitis Sicca', 'orgStudyIdInfo': {'id': 'LX214-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LX214 0.02%', 'description': 'LX214 ophthalmic solution 0.02%', 'interventionNames': ['Drug: voclosporin ophthalmic solution']}, {'type': 'EXPERIMENTAL', 'label': 'LX214 0.2%', 'interventionNames': ['Drug: voclosporin ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Drug: voclosporin ophthalmic solution']}], 'interventions': [{'name': 'voclosporin ophthalmic solution', 'type': 'DRUG', 'description': '0.02%, 0.2% t.i.d. or b.i.d.', 'armGroupLabels': ['LX214 0.02%', 'LX214 0.2%', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19428', 'city': 'Conshohocken', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Product Investigations', 'geoPoint': {'lat': 40.07928, 'lon': -75.30157}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lux Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}