Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-29 @ 10:04 AM
Study NCT ID:
NCT00765804
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2008-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'dispFirstSubmitDate': '2010-08-20', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-27', 'studyFirstSubmitDate': '2008-10-02', 'dispFirstSubmitQcDate': '2010-08-20', 'studyFirstSubmitQcDate': '2008-10-02', 'dispFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sign: Corneal fluorescein staining after CAE exposure at Visit 5', 'timeFrame': 'Visit 5 (Day 7 ± 2 Days)', 'description': 'Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.'}, {'measure': 'Symptom: Ocular discomfort during CAE exposure at Visit 5', 'timeFrame': 'Visit 5 (Day 7 ± 2 Days)', 'description': 'Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale.'}], 'secondaryOutcomes': [{'measure': 'Sign: Fluorescein staining at each visit over 3 weeks', 'timeFrame': '7 visits / 3 weeks', 'description': 'Fluorescein staining (each region) as measured by the ORA and NEI Scales at each of 7 visits over 3 weeks'}, {'measure': 'Symptom: Ocular discomfort pre and post CAE', 'timeFrame': 'Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days)', 'description': 'Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Eye', 'Iontophoresis', 'Ophthalmic Delivery'], 'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.', 'detailedDescription': 'The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo for the treatment of the signs and symptoms of dry eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a reported history of dry eye in each eye\n* Be at least 12 years of age\n* Demonstrate a response when exposed to the Controlled Adverse Environment model\n\nExclusion Criteria:\n\n* Have contraindications to the use of the test articles\n* Have known allergy or sensitivity to the study medication or their components (including corticosteroids)\n* Have any ocular infections, active ocular inflammation or preauricular lymphadenopathy\n* Be current contact lens wearers or wear contacts during the study'}, 'identificationModule': {'nctId': 'NCT00765804', 'briefTitle': 'Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eyegate Pharmaceuticals, Inc.'}, 'officialTitle': 'Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model', 'orgStudyIdInfo': {'id': 'EGP-437-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low Dose: DP 7.5 mA-min at 2.5 mA', 'description': 'Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA', 'interventionNames': ['Drug: EGP-437 with EyeGate® II System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Dose: DP 10.5 mA-min at 3.5 mA', 'description': 'Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA', 'interventionNames': ['Drug: EGP-437 with EyeGate® II System']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo: 10.5 mA-min at 3.5 mA', 'description': 'Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA)', 'interventionNames': ['Drug: Sodium citrate buffer solution with EyeGate® II System']}], 'interventions': [{'name': 'EGP-437 with EyeGate® II System', 'type': 'DRUG', 'otherNames': ['Dexamethasone phosphate ophthalmic solution'], 'description': 'Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System', 'armGroupLabels': ['High Dose: DP 10.5 mA-min at 3.5 mA', 'Low Dose: DP 7.5 mA-min at 2.5 mA']}, {'name': 'Sodium citrate buffer solution with EyeGate® II System', 'type': 'DRUG', 'otherNames': ['Sodium citrate buffer solution'], 'description': 'Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System', 'armGroupLabels': ['Placebo: 10.5 mA-min at 3.5 mA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Research Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '01845', 'city': 'North Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Research Associates', 'geoPoint': {'lat': 42.6987, 'lon': -71.13506}}], 'overallOfficials': [{'name': 'Gail Torkildsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ORA, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyegate Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Stephen From/Chief Executive Officer', 'oldOrganization': 'Eyegate Pharmaceuticals, Inc.'}}}}