Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-26 @ 1:39 PM
Study NCT ID:
NCT05356793
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2022-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-15', 'mcpReleaseN': 2, 'releaseDate': '2024-09-23'}, {'resetDate': '2024-11-18', 'mcpReleaseN': 3, 'releaseDate': '2024-10-26'}], 'estimatedResultsFirstSubmitDate': '2024-09-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003231', 'term': 'Conjunctivitis'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2022-04-10', 'studyFirstSubmitQcDate': '2022-04-26', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Resolution Among Who Received SCH1 or Placebo on Day 5', 'timeFrame': 'Day 5', 'description': 'Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 3 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SCH1 and placebo reporting groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Conjunctivitis', 'Eye'], 'conditions': ['Acute Infectious Conjunctivitis (Disorder)']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy of Sasch1, a novel anti-infective eyedrop, in the treatment of acute infectious conjunctivitis.', 'detailedDescription': 'This is a Phase II single-center, double-masked, placebo controlled, randomized study of SCH1 for the treatment of infectious conjunctivitis. Approximately 30 subjects will be enrolled, who will be randomized in a 1:1 ratio between SCH1and placebo. Subjects will be assessed at day 1, day 3, and day 5 for efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Conjunctivitis (as defined below) within 72 hours of initial ocular symptoms.\n* At least 18 years of age.\n* Subjects capable of understanding the purpose and risks of the study, and able to give informed consent.\n* Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis- 1) bulbar conjunctival injection and 2) conjunctival discharge/exudates.\n* A three-point rating scale (0=absent, 1=mild, 2=moderate, 3=severe) will be employed to grade conjunctival discharge/exudates.\n* All patients will require a rating of 1(mild) or greater for conjunctival discharge/exudates.\n* Patients will require a rating of 1 (mild) for bulbar conjunctival injection.\n\nExclusion Criteria:\n\n* Conjunctivitis greater than 72 hours after initial ocular symptoms\n* Corneal ulcer, endophthalmitis, or any other confounding infection of the eye\n* Patients taking topical anti-inflammatory medications on a chronic basis\n* Known steroid glaucoma responders\n* Active herpes ocular infection\n* Pregnant women\n* Known allergy to chlorhexidine'}, 'identificationModule': {'nctId': 'NCT05356793', 'acronym': 'SCH1TAIC', 'briefTitle': 'The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sacsh'}, 'officialTitle': 'A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis', 'orgStudyIdInfo': {'id': 'SCH-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Active treatment with SCH-1', 'interventionNames': ['Drug: SCH-1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Vehicle minus active components', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SCH-1', 'type': 'DRUG', 'description': 'Novel anti-infective eyedrop', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'SCH-1 vehicle minus active components eyedrop', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11372', 'city': 'Jackson Heights', 'state': 'New York', 'country': 'United States', 'facility': 'Jacqueline Dauhajre, MD', 'geoPoint': {'lat': 40.75566, 'lon': -73.88541}}], 'overallOfficials': [{'name': 'David Ritterband, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sacsh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sacsh', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}