Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT01129856
Status:
COMPLETED
Last Update Posted:
2011-04-27
First Post:
2010-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of EGP-437 (Dexamethasone Phosphate Formulated for Ocular Iontophoresis) to Treat Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-01-20', 'releaseDate': '2020-12-29'}, {'resetDate': '2021-02-11', 'releaseDate': '2021-01-25'}], 'estimatedResultsFirstSubmitDate': '2020-12-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-25', 'studyFirstSubmitDate': '2010-05-20', 'studyFirstSubmitQcDate': '2010-05-22', 'lastUpdatePostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sign: Differences in corneal fluorescein staining (inferior region, Ora Scale) Visit 1 Pre-CAE to Visit 6 compared to placebo; Symptom: Ocular discomfort at Visit 5 as compared to placebo', 'timeFrame': 'Up to 10 weeks'}], 'secondaryOutcomes': [{'measure': 'Sign: Corneal fluorescein staining (each region, Ora Scale); Symptom: Ocular discomfort pre- and post-CAE (Ora Scale)', 'timeFrame': 'Up to 10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry eye', 'Keratoconjunctivitis sicca', 'Iontophoresis', 'Ophthalmic drug delivery', 'EGP-437', 'Dexamethasone phosphate'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in patients with dry eye.', 'detailedDescription': 'Dry eye is the most prevalent form of ocular discomfort and irritation. Estimates range from 20 million people in the United States being affected with mild to moderate dry eye, to as many as one out of every five Americans.\n\nEyeGate completed a single-center, randomized, double-masked, placebo-controlled Phase 2 efficacy study in 105 subjects with mild to moderate dry eye disease, utilizing the Controlled Adverse Environment (CAE), a clinical model which allows for standardized measurement of dry eye signs and symptoms in the investigation of therapeutic agents. In this Phase 2 study, the improvements documented in dry eye signs and symptoms relative to the placebo group indicated that the ocular iontophoresis treatments with EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) had both a rapid onset of action and a long-term effectiveness.\n\nThe Phase 3 study is intended to confirm and extend the results from the Phase 2 study, utilizing the CAE model. The study is designed to assess the safety and efficacy of EGP-437 at two different dose levels: Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA compared to Ocular Iontophoresis with placebo (sodium citrate buffer solution) 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 at Visits 1 and 2\n\nExclusion Criteria:\n\n* Have contraindications to the use of the test articles\n* Have known allergy or sensitivity to the study medications or their components\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': 'NCT01129856', 'briefTitle': 'Safety and Efficacy Study of EGP-437 (Dexamethasone Phosphate Formulated for Ocular Iontophoresis) to Treat Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eyegate Pharmaceuticals, Inc.'}, 'officialTitle': 'Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model', 'orgStudyIdInfo': {'id': 'EGP-437-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ocular Iontophoresis EGP-437, Low Dose', 'description': 'Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA', 'interventionNames': ['Drug: Dexamethasone phosphate ophthalmic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ocular Iontophoresis EGP-437, High Dose', 'description': 'Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA', 'interventionNames': ['Drug: Dexamethasone phosphate ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ocular Iontophoresis Placebo', 'description': 'Ocular Iontophoresis with Placebo 6.5 mA-min at 2.5 mA', 'interventionNames': ['Drug: Sodium citrate buffer solution']}], 'interventions': [{'name': 'Dexamethasone phosphate ophthalmic solution', 'type': 'DRUG', 'description': 'Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)', 'armGroupLabels': ['Ocular Iontophoresis EGP-437, High Dose', 'Ocular Iontophoresis EGP-437, Low Dose']}, {'name': 'Sodium citrate buffer solution', 'type': 'DRUG', 'description': 'Sodium citrate buffer solution 100 mM', 'armGroupLabels': ['Ocular Iontophoresis Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Eye Care Group', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '04240', 'city': 'Lewiston', 'state': 'Maine', 'country': 'United States', 'facility': 'Central Maine Eye Care', 'geoPoint': {'lat': 44.10035, 'lon': -70.21478}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Eye Consultants', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Gail L Torkildsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andover Eye Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyegate Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Stephen From / President and Chief Executive Officer', 'oldOrganization': 'Eyegate Pharmaceuticals, Inc.'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-12-29', 'type': 'RELEASE'}, {'date': '2021-01-20', 'type': 'RESET'}, {'date': '2021-01-25', 'type': 'RELEASE'}, {'date': '2021-02-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Eyegate Pharmaceuticals, Inc.'}}}}