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The objective of this study is to evaluate the efficacy of Sasch1, a novel anti-infective eyedrop, in the treatment of acute infectious conjunctivitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Active treatment with SCH-1 |
|
| Placebo | Placebo Comparator | Vehicle minus active components |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH-1 | Drug | Novel anti-infective eyedrop |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clinical Resolution | Clinical score of 0 (zero) for both Conjunctival Injection (Minimum score: 0, maximum score: 3, 0 is best outcome) and Conjunctival Discharge (minimum score: 0, maximum score 3, 0 is best outcome). | Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ritterband, MD | Sacsh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacqueline Dauhajre, MD | Jackson Heights | New York | 11372 | United States |
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March 1, 2021 to March 28, 2022, Single Private Practice Clinical Site
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Active treatment with SCH-1, a novel anti-infective eyedrop |
| FG001 | Placebo | Placebo: SCH-1 vehicle minus active components eyedrop |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Active treatment with SCH-1 |
| BG001 | Placebo | Placebo: SCH-1 vehicle minus active components eyedrop |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Clinical Resolution | Clinical score of 0 (zero) for both Conjunctival Injection (Minimum score: 0, maximum score: 3, 0 is best outcome) and Conjunctival Discharge (minimum score: 0, maximum score 3, 0 is best outcome). | Posted | Count of Participants | Participants | Day 5 |
|
|
5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Active treatment with SCH-1 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort upon instillation of drop | Eye disorders | Systematic Assessment |
Caveat: While designed to evaluate efficacy in any type of infectious conjunctivitis, the majority of patients recruited turned out to have viral conjunctivitis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Uri Shabto | Sacsh | 914-552-7705 | ushabto@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2026 | Apr 1, 2026 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 27, 2020 | Sep 23, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| Drug |
SCH-1 vehicle minus active components eyedrop |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Conjunctival injection score of 2 or greater | 0 = No injection
| Count of Participants | Participants |
|
| Conjunctival discharge score of 2 or greater | 0 = Absent
| Count of Participants | Participants |
|
| Participants |
|
|
| 16 |
| 0 |
| 16 |
| 8 |
| 16 |
| EG001 | Placebo | Placebo: SCH-1 vehicle minus active components eyedrop | 0 | 14 | 0 | 14 | 4 | 14 |
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