Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT04899518
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2021-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-16', 'mcpReleaseN': 5, 'releaseDate': '2024-08-27'}], 'estimatedResultsFirstSubmitDate': '2024-08-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 922}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-05-19', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal fluorescein staining', 'timeFrame': '8 weeks', 'description': 'Difference between ALY688 Ophthalmic Solution 0.4% and vehicle'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease', 'detailedDescription': 'Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dry eye disease for \\> 3 months meeting specific sign and symptom criteria\n* Best corrected visual acuity of +0.6 logMAR or better\n* Willing to sign informed consent and attend study visits\n* Willing to comply with contraception requirements\n\nExclusion Criteria:\n\n* Unable to meet specific sign and symptom criteria\n* Signs of ophthalmic allergic, inflammatory or infection conditions\n* Use of contact lenses\n* Anatomic abnormalities preventing accurate study assessments\n* Use of medications that influence eye dryness\n* Recent ophthalmic surgery\n* Unwilling to suspend current treatments for dry eye disease'}, 'identificationModule': {'nctId': 'NCT04899518', 'acronym': 'OASIS-1', 'briefTitle': 'ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allysta Pharmaceutical'}, 'officialTitle': 'A Phase 2b/3, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)', 'orgStudyIdInfo': {'id': 'ALY688-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Ophthalmic Solution', 'interventionNames': ['Drug: ALY688 Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'ALY688 Ophthalmic Solution Concentration 1', 'interventionNames': ['Drug: ALY688 Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'ALY688 Ophthalmic Solution Concentration 2', 'interventionNames': ['Drug: ALY688 Ophthalmic Solution']}], 'interventions': [{'name': 'ALY688 Ophthalmic Solution', 'type': 'DRUG', 'description': 'Ophthalmic Solution', 'armGroupLabels': ['ALY688 Ophthalmic Solution Concentration 1', 'ALY688 Ophthalmic Solution Concentration 2', 'Vehicle Ophthalmic Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Allysta Pharmaceuticals', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allysta Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}