Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-02-01 @ 9:04 PM
Study NCT ID:
NCT02078661
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2013-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of PG101 for Dry Eye Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2016-02-19', 'unreleaseDateUnknown': True}, {'resetDate': '2016-04-07', 'releaseDate': '2016-03-09'}], 'estimatedResultsFirstSubmitDate': '2016-02-19'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-03', 'studyFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2014-03-03', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'At least one dry eye ocular symptom', 'timeFrame': 'Up to 2 weeks', 'description': 'Dry eye ocular symptoms measured are: Ocular discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing.'}], 'secondaryOutcomes': [{'measure': 'At least one dry eye ocular sign measure.', 'timeFrame': 'Up to 2 weeks', 'description': 'Dry eye ocular signs measured are: Corneal and conjunctival staining, tear break up time, OPI 2.0, Schirmer tear test, quality of life, and conjunctival redness'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Keratoconjunctivitis sicca', 'Dry eye'], 'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome', 'detailedDescription': 'The topical product PG101 is expected to be efficacious in treating the symptoms of dry eye such as discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing. Two concentrations (0.25% and 1.0%) are included in the study to determine if there is a dose response effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be male or female of any race, at least 18 years of age\n* Have provided verbal and written informed consent\n* Be able and willing to follow instructions, including participation in all study assessments and visits\n* Have a reported history of dry eye syndrome\n* Have a history of use or desire to use eye drops for dry eye\n* If a woman of childbearing potential, have a negative pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period\n* Have a best corrected visual acuity of +0.70 logMAR or better in both eyes\n\nExclusion Criteria:\n\n* Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters\n* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1\n* Be a woman who is pregnant, nursing or planning a pregnancy\n* Have a known allergy and/or sensitivity to the test article 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 study results, or may interfere significantly with the subject's participation in the study\n* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1"}, 'identificationModule': {'nctId': 'NCT02078661', 'acronym': 'PG101', 'briefTitle': 'Safety and Efficacy of PG101 for Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rhodes Pharmaceuticals, L.P.'}, 'officialTitle': 'A Single Center, Randomized, Double-Masked, Placebo Controlled Study Evaluating the Safety and Efficacy of 0.25% PG101 and 1.0% PG101 in Subjects With Dry Eye Syndrome', 'orgStudyIdInfo': {'id': 'RP-PG-EF001'}, 'secondaryIdInfos': [{'id': '13-110-0002', 'type': 'OTHER', 'domain': 'Rhodes Pharmaceuticals L.P.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PG101 0.25%', 'description': 'Topical application of drug', 'interventionNames': ['Drug: PG101']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PG101 1.0%', 'description': 'Topical application of drug', 'interventionNames': ['Drug: PG101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Topical application of placebo', 'interventionNames': ['Drug: PG101']}], 'interventions': [{'name': 'PG101', 'type': 'DRUG', 'otherNames': ['Topical gel', 'Topical gel suspension'], 'description': 'A topical gel containing either 1% or 0.25% PG101 active.', 'armGroupLabels': ['PG101 0.25%', 'PG101 1.0%', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'overallOfficials': [{'name': 'Gail Torkildsen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andover Eye'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhodes Pharmaceuticals, L.P.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-02-19', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2016-03-09', 'type': 'RELEASE'}, {'date': '2016-04-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rhodes Pharmaceuticals, L.P.'}}}}