Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 7:55 AM
Study NCT ID:
NCT05370495
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
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Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20).'}, {'measure': 'Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60', 'timeFrame': '60 days', 'description': 'Eye dryness score as measure by visual analog scale (0 (none) to 100 (severe)) was used to as efficacy meaure for dry eye symptom improvement. This outcome measure focused on self reported extent of eye dryness.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60', 'timeFrame': '60 days', 'description': 'Cornea is divided into 5 regions. 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Are 18 years of age or older.\n 3. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.\n 4. Have a Best Corrected Visual Acuity (BCVA) in each eye, using corrective lenses if necessary, of +0.7 logarithm of the minimum angle of resolution (LogMAR) or better as assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) at Visit 1.\n\nExclusion Criteria:\n\n1. Unanesthetized Schirmer test score in either eye \\<2 mm/5 minutes at Visit 1.\n2. Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial\n3. Have corneal erosive disease (e.g., confluent staining \\[National Eye Institute (NEI) grade 4\\], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.\n4. Have a history of glaucoma or intraocular pressure (IOP) \\>25 mmHg at Visit 1 or a history of elevated IOP (\\>25 mmHg) in either eye.\n5. Wear contact lenses for 14 days prior to Visit 1 or throughout the study.'}, 'identificationModule': {'nctId': 'NCT05370495', 'briefTitle': 'Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seinda Pharmaceutical Guangzhou Corporation'}, 'officialTitle': 'A Phase 2, Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Dose-Response, Parallel-Group Study of SY-201 Ophthalmic Solution Versus Vehicle Control in Subjects With Dry Eye Disease', 'orgStudyIdInfo': {'id': 'SY201-CS201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SY-201 Ophthalmic Solution 2.0%', 'description': 'SY-201 Ophthalmic Solution 2.0%', 'interventionNames': ['Drug: SY-201 Ophthalmic Solution 2.0%']}, {'type': 'EXPERIMENTAL', 'label': 'SY-201 Ophthalmic Solution 1.0%', 'description': 'SY-201 Ophthalmic Solution 1.0%', 'interventionNames': ['Drug: SY-201 Ophthalmic Solution 1.0%']}, {'type': 'EXPERIMENTAL', 'label': 'SY-201 Ophthalmic Solution 0.5%', 'description': 'SY-201 Ophthalmic Solution 0.5%', 'interventionNames': ['Drug: SY-201 Ophthalmic Solution 0.5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SY-201 Ophthalmic Solution Vehicle', 'description': 'SY-201 Ophthalmic Solution Vehicle', 'interventionNames': ['Drug: SY-201 Ophthalmic Solution Vehicle']}], 'interventions': [{'name': 'SY-201 Ophthalmic Solution 2.0%', 'type': 'DRUG', 'description': 'SY-201 Ophthalmic Solution 2.0%', 'armGroupLabels': ['SY-201 Ophthalmic Solution 2.0%']}, {'name': 'SY-201 Ophthalmic Solution 1.0%', 'type': 'DRUG', 'description': 'SY-201 Ophthalmic Solution 1.0%', 'armGroupLabels': ['SY-201 Ophthalmic Solution 1.0%']}, {'name': 'SY-201 Ophthalmic Solution 0.5%', 'type': 'DRUG', 'description': 'SY-201 Ophthalmic Solution 0.5%', 'armGroupLabels': ['SY-201 Ophthalmic Solution 0.5%']}, {'name': 'SY-201 Ophthalmic Solution Vehicle', 'type': 'DRUG', 'description': 'SY-201 Ophthalmic Solution Vehicle', 'armGroupLabels': ['SY-201 Ophthalmic Solution Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27703', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lexitas', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seinda Pharmaceutical Guangzhou Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}