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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. | 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 1) |
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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 | Chandler | Arizona | 85225 | 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. |
|
| 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 occurred 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 occurred 2 hours following Dose 1) |
| Mesa |
| Arizona |
| 85202 |
| United States |
| Orasis Investigative Site | Phoenix | Arizona | 85032 | United States |
| Orasis Investigative Site | Garden Grove | California | 92843 | United States |
| Orasis Investigative Site | Mission Hills | California | 91345 | United States |
| Orasis Investigative Site | Newport Beach | California | 92663 | United States |
| Orasis Investigative Site | Petaluma | California | 94954 | United States |
| Orasis Investigative Site | Littleton | Colorado | 80120 | United States |
| Orasis Investigative Site | Danbury | Connecticut | 06810 | United States |
| Orasis Investigative Site | Delray Beach | Florida | 33484 | United States |
| Orasis Investigative Site | Rock Island | Illinois | 61201 | United States |
| Orasis Investigative Site | Rochester | New York | 14618 | United States |
| Orasis Investigative Site | Kingston | Pennsylvania | 18704 | United States |
| Orasis Investigative Site | Cedar Park | Texas | 78613 | United States |
| Orasis Investigative Site | San Antonio | Texas | 78229 | United States |
| Orasis Investigative Site | Clinton | Utah | 84015 | United States |
| Orasis Investigative Site | Draper | Utah | 84020 | United States |
| Orasis Investigative Site | Lynchburg | Virginia | 24502 | United States |
| COMPLETED |
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| NOT COMPLETED |
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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) | MRSE: is the measure which allows to identify if a person is myopic (nearsighted) < -0.5D; emmetropic (normal refractive condition) 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. | 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 occurred 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 occurred 2 hours following Dose 1) |
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15 days
One subject was randomized to CSF-1 and inadvertently received Vehicle. For the safety results, the subjects were analyzed as treated (and not as randomized). Therefore the number of participants in each group is different from the numbers stated in the Participant Flow.
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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 | 153 | 0 | 153 | 35 | 153 |
| EG001 | Vehicle | One drop bilaterally twice daily for approximately 2 weeks. Vehicle: One drop bilaterally twice daily for approximately 2 weeks. | 0 | 151 | 1 | 151 | 2 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infective arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment | One (0.7%) SAE, an infective arthritis event in the knee was reported by a vehicle treated subject who required hospitalization. It was deemed not related to the study drug. The subject was then lost to follow-up despite multiple contact attempts. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vision blurred | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| 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 24, 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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| Brown 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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