Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 4:05 AM
Study NCT ID:
NCT07277257
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from pre-instillation to 3 minutes post-TRYPTYR instillation in study eye unanesthetized Schirmer's test at Visit 1 (baseline)", 'timeFrame': '3 minutes', 'description': "Unanesthetized Schirmer's test will be measured prior to instillation and then again 3 minutes after instillation of the TRYPTYR. The difference between the 2 measurements will be compared."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sjogren Syndrome With Keratoconjunctivitis']}, 'descriptionModule': {'briefSummary': "This study will evaluate the effect of TRYPTYR in patients with Sjögren's syndrome-related dry eye disease. The goal is to determine whether TRYPTYR can improve symptoms and signs of dry eye in this specific patient population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects must fulfill the following conditions to qualify for enrollment into the trial\n\n1. Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years.\n2. History of using or desiring artificial tears for DED symptoms within the past 2 months.\n3. Unanesthetized Schirmer's Test (UA ST) score ≥1 and \\< 10 mm/5 min and baseline total Corneal Fluorescein Staining (tCFS) score ≥2 and ≤ 15 (National Eye Institute, NEI, grading scale).\n\nExclusion Criteria:\n\nSubjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.\n\n1. History of ocular surgery within the past 6 months.\n2. Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study\n3. On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period.\n4. Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period.\n5. Use of artificial tears within 2 hours prior to the baseline or study visit days.\n6. Any known allergies to any component of the study drug.\n7. Severe, uncontrolled autoimmune disease (e.g., rheumatoid arthritis, lupus). Uncontrolled is at the discretion of the PI. Subjects with severe systemic symptoms will not be included."}, 'identificationModule': {'nctId': 'NCT07277257', 'briefTitle': "Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Center For Sight'}, 'officialTitle': "Evaluating TRYPTYR as a Novel Therapy for Dry Eye in Patients With Sjögren's Syndrome", 'orgStudyIdInfo': {'id': 'CFS25-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study eye', 'description': 'The study eye is the eye with the lower pre-drop unanesthetized Schirmer score performed at the baseline visit.', 'interventionNames': ['Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%)']}], 'interventions': [{'name': 'TRYPTYR (Acoltremon ophthalmic solution 0.003%)', 'type': 'DRUG', 'description': 'Drop to be instilled before and after endpoint measurement.', 'armGroupLabels': ['Study eye']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34285', 'city': 'Venice', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gina Thomas', 'role': 'CONTACT', 'email': 'gthomas@centerforsight.net', 'phone': '941-263-4784'}], 'facility': 'Center For Sight', 'geoPoint': {'lat': 27.09978, 'lon': -82.45426}}], 'centralContacts': [{'name': 'Gina Thomas', 'role': 'CONTACT', 'email': 'gina.thomas@useye.com', 'phone': '9412634784'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center For Sight', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}