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This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSF-1 | Experimental | One drop bilaterally twice daily for approximately 2 weeks. |
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| Vehicle | Placebo Comparator | One drop bilaterally twice daily for approximately 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSF-1 | Drug | One drop bilaterally twice daily for approximately 2 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. | The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment. A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m. | Baseline (Day 1) to Day 8 (1 hour post-Dose 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-Dose 1 | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects must not:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orasis Investigative Site | Sun City | Arizona | 85351 | United States | ||
| Orasis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38216351 | Derived | Holland E, Karpecki P, Fingeret M, Schaeffer J, Gupta P, Fram N, Smits G, Ignacio T, Lindstrom R. Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials. Clin Ther. 2024 Feb;46(2):104-113. doi: 10.1016/j.clinthera.2023.12.005. Epub 2024 Jan 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CSF-1 | One drop bilaterally twice daily for approximately 2 weeks. CSF-1: One drop bilaterally twice daily for approximately 2 weeks. |
| FG001 | Vehicle | One drop bilaterally twice daily for approximately 2 weeks. Vehicle: One drop bilaterally twice daily for approximately 2 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 7, 2021 | Nov 12, 2023 |
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| Vehicle | Drug | One drop bilaterally twice daily for approximately 2 weeks. |
|
| Baseline (Day 1) to Day 8 (2 hours post-Dose 1) |
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2 | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. | Baseline (Day 1) to Day 8 (1 hour post-Dose 2; Dose 2 occurs 2 hours following Dose 1) |
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2 | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. | Baseline (Day 1) to Day 8 (2 hours post-Dose 2; Dose 2 occurs 2 hours following Dose 1) |
| Glendale |
| California |
| 91204 |
| United States |
| Orasis Investigative Site | Los Angeles | California | 90013 | United States |
| Orasis Investigative Site | Fort Myers | Florida | 33901 | United States |
| Orasis Investigative Site | Mt. Dora | Florida | 32757 | United States |
| Orasis Investigative Site | Morrow | Georgia | 30260 | United States |
| Orasis Investigative Site | Overland Park | Kansas | 66210 | United States |
| Orasis Investigative Site | Louisville | Kentucky | 40206 | United States |
| Orasis Investigative Site | Kansas City | Missouri | 64133 | United States |
| Orasis Investigative Site | St Louis | Missouri | 63131 | United States |
| Orasis Investigative Site | Henderson | Nevada | 89052 | United States |
| Orasis Investigative Site | Elizabeth City | North Carolina | 27909 | United States |
| Orasis Investigative Site | Cranberry Township | Pennsylvania | 16066 | United States |
| Orasis Investigative Site | Wilkes-Barre | Pennsylvania | 18702 | United States |
| Orasis Investigative Site | Rapid City | South Dakota | 57701 | United States |
| Orasis Investigative Site | Memphis | Tennessee | 38119 | United States |
| Orasis Investigative Site | El Paso | Texas | 79902 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The subject demographics and characteristics presented are for the Full Analysis Set (FAS).
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| ID | Title | Description |
|---|---|---|
| BG000 | CSF-1 | One drop bilaterally twice daily for approximately 2 weeks. CSF-1: One drop bilaterally twice daily for approximately 2 weeks. |
| BG001 | Vehicle | One drop bilaterally twice daily for approximately 2 weeks. Vehicle: One drop bilaterally twice daily for approximately 2 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Iris Color | Count of Participants | Participants |
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| Manifest Refraction Spherical Equivalent (MRSE) | Measure Description: MRSE: is the measure which allows to identify if a person is myopic (nearsighted) < -0.5D; emmetropic (normal refractive conditions) between -0.5D to <= +0.75D: or hyperopic (farsighted) >+0.75D. | Count of Participants | Participants |
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| 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 | Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. | The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment. A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m. | Full analysis set (FAS): included all randomized subjects who received at least 1 dose of the study drug. Subjects in the FAS were analyzed as randomized. | Posted | Count of Participants | Participants | Baseline (Day 1) to Day 8 (1 hour post-Dose 1) |
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| Secondary | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-Dose 1 | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. | Posted | Count of Participants | Participants | Baseline (Day 1) to Day 8 (2 hours post-Dose 1) |
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| Secondary | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2 | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. | Posted | Count of Participants | Participants | Baseline (Day 1) to Day 8 (1 hour post-Dose 2; Dose 2 occurs 2 hours following Dose 1) |
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| Secondary | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2 | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. | Posted | Count of Participants | Participants | Baseline (Day 1) to Day 8 (2 hours post-Dose 2; Dose 2 occurs 2 hours following Dose 1) |
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15 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 | CSF-1 | One drop bilaterally twice daily for approximately 2 weeks. CSF-1: One drop bilaterally twice daily for approximately 2 weeks. | 0 | 155 | 0 | 155 | 17 | 155 |
| EG001 | Vehicle | One drop bilaterally twice daily for approximately 2 weeks. Vehicle: One drop bilaterally twice daily for approximately 2 weeks. | 0 | 154 | 1 | 154 | 3 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enteritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment | One (0.6%) SAE of enteritis was reported in the Vehicle group, which required hospitalization. The subject was discontinued from the study after Day 26, and the event was resolved at the time of discontinuation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| instillation site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
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| headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Regulatory Affairs | Orasis Pharmaceuticals, Ltd. | +972-9-8877745 | iris.meisner@orasis-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2022 | Nov 12, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016173 | Macrophage Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Dark Iris Color |
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| -0.5 D to <= +0.75 D |
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| > +0.75 D to +2.0 D |
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