Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-02 @ 10:15 AM
Study NCT ID:
NCT01468168
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2011-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-05-19', 'releaseDate': '2017-04-14'}], 'estimatedResultsFirstSubmitDate': '2017-04-14'}}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-14', 'studyFirstSubmitDate': '2011-11-07', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear volume increase from baseline', 'timeFrame': 'baseline and 6 months'}]}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals considered for entry into the study will be of either sex and any race who have:\n* a confirmed diagnosis of dry eye,\n* are willing to use no ocular treatments during the study other than study medication,\n* have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,\n* will not use contact lenses during the study,\n* Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,\n* 18 years of age or older,\n* able to understand and provide written informed consent\n\nExclusion Criteria:\n\n* Subjects with any of the following are not eligible to participate in the study:\n* Fluorescein corneal staining or conjunctival staining that is too severe\n* Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)\n* Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta\n* Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)\n* Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid\n* Ocular(including lid)disease/abnormality that may interfere with the study\n* Corneal transplant in either eye, at any time prior to enrollment in the study\n* Laser refractive surgery less than one year prior to Visit 1 (Day 1)\n* Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)\n* Application of isotretinoin within 30 days prior to Visit 1 (Day 1)\n* Known allergy or sensitivity to any of the study medication components\n* Uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject\n* A woman who is pregnant, nursing, or planning a pregnancy\n* Participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to Visit 1 (Day 1)"}, 'identificationModule': {'nctId': 'NCT01468168', 'briefTitle': 'A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Inc.'}, 'officialTitle': 'A Phase II Prospective, Randomized, Double-Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Ophthalmic Suspension Compared to Placebo for the Treatment of Dry Eye Disease', 'orgStudyIdInfo': {'id': '26-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DE-101 Ophthalmic Suspension High Dose', 'interventionNames': ['Drug: DE-101 Ophthalmic Suspension']}, {'type': 'EXPERIMENTAL', 'label': 'DE-101 Ophthalmic Suspension Low Dose', 'interventionNames': ['Drug: DE-101 Ophthalmic Suspension']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'DE-101 Ophthalmic Suspension Vehicle', 'interventionNames': ['Drug: DE-101 Ophthalmic Suspension Vehicle']}], 'interventions': [{'name': 'DE-101 Ophthalmic Suspension', 'type': 'DRUG', 'description': 'Ophthalmic suspension; QID', 'armGroupLabels': ['DE-101 Ophthalmic Suspension High Dose']}, {'name': 'DE-101 Ophthalmic Suspension', 'type': 'DRUG', 'description': 'Ophthalmic suspension; QID', 'armGroupLabels': ['DE-101 Ophthalmic Suspension Low Dose']}, {'name': 'DE-101 Ophthalmic Suspension Vehicle', 'type': 'DRUG', 'description': 'Ophthalmic suspension vehicle; QID', 'armGroupLabels': ['DE-101 Ophthalmic Suspension Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'New Port Beach', 'state': 'California', 'country': 'United States'}, {'zip': '80134', 'city': 'Parker', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.5186, 'lon': -104.76136}}, {'zip': '33773', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '30260', 'city': 'Morrow', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.58317, 'lon': -84.33937}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63090', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '44115', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-04-14', 'type': 'RELEASE'}, {'date': '2017-05-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Santen Inc.'}}}}