Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01733992
Status:
COMPLETED
Last Update Posted:
2014-08-04
First Post:
2012-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-31', 'studyFirstSubmitDate': '2012-11-21', 'studyFirstSubmitQcDate': '2012-11-26', 'lastUpdatePostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Schirmer test', 'timeFrame': 'Baseline and Visits 4, 8 and 12'}], 'primaryOutcomes': [{'measure': 'Change in corneal fluorescein staining', 'timeFrame': 'Baseline and Visits 4, 8 and 12'}], 'secondaryOutcomes': [{'measure': 'Change in conjunctival lissamine green staining', 'timeFrame': 'Baseline and Visits 4, 8 and 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Keratoconjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered in patients with mild to moderate keratoconjunctivitis sicca (KCS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate Keratoconjunctivitis Sicca.\n* A corrected visual acuity in both eyes of 20/40 or better.\n* An intraocular pressure of \\< 21 mm Hg with a difference between eyes of \\< 6 mm Hg.\n\nExclusion Criteria:\n\n* History or evidence of ocular infection, inflammation, or conjunctivitis within 2 months prior to the first dosing day.\n* History or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day.\n* History of herpes simplex keratitis at any time.\n* Current ocular allergy symptoms.\n* Recent use of eye medications such as steroids or cyclosporine\n* Refractive eye surgery within 12 months of the first dosing day.\n* Other eye surgeries within 4 months of the first dosing day.\n* Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.\n* Receipt of any blood or blood products within 90 days prior to the first dosing day.\n* Participation in any clinical study within 30 days prior to the first dosing day.\n* History of disease, or currently have a significant illness or abnormal laboratory finding as determined by your study doctor.\n* Positive for hepatitis B, hepatitis C or HIV.\n* Smoked regularly within 12 months of first dosing day.\n* History of substance abuse, drug addiction or alcoholism.'}, 'identificationModule': {'nctId': 'NCT01733992', 'briefTitle': 'A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rigel Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Pharmacokinetics, Tolerability and Safety Study of R932348 Ophthalmic Solution in Patients With Mild to Moderate Keratoconjunctivitis Sicca', 'orgStudyIdInfo': {'id': 'C-932348-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'R348 Ophthalmic Solution, 0.2%', 'description': 'R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.', 'interventionNames': ['Drug: R348 Ophthalmic Solution, 0.2%', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'R348 Ophthalmic Solution, 0.5%', 'description': 'R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.', 'interventionNames': ['Drug: R348 Ophthalmic Solution, 0.5%', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'R348 Ophthalmic Solution, 1.0%', 'description': 'R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.', 'interventionNames': ['Drug: R348 Ophthalmic Solution, 1.0%', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'R348 Ophthalmic Solution, 0.2%', 'type': 'DRUG', 'otherNames': ['R932348'], 'description': 'R348 Ophthalmic Solution, 0.2% single and multiple ascending dose', 'armGroupLabels': ['R348 Ophthalmic Solution, 0.2%']}, {'name': 'R348 Ophthalmic Solution, 0.5%', 'type': 'DRUG', 'otherNames': ['R932348'], 'description': 'R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose', 'armGroupLabels': ['R348 Ophthalmic Solution, 0.5%']}, {'name': 'R348 Ophthalmic Solution, 1.0%', 'type': 'DRUG', 'otherNames': ['R932348'], 'description': 'R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose', 'armGroupLabels': ['R348 Ophthalmic Solution, 1.0%']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, single and multiple ascending dose', 'armGroupLabels': ['Placebo', 'R348 Ophthalmic Solution, 0.2%', 'R348 Ophthalmic Solution, 0.5%', 'R348 Ophthalmic Solution, 1.0%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'overallOfficials': [{'name': 'Gail Torkildsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andover Eye Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigel Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}