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This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia.
This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia. Approximately 150 subjects will be enrolled across 7 study centers in the United States. At Visit 2, subjects will be randomized 1:1:1 to one of three treatment arms: CSF-1, CSF-1 Component #1, or CSF-1 Component #2. All subjects will dose twice a day in both eyes with a single drop of their assigned treatment for approximately 1 week. At Visit 3, subjects randomized to CSF-1 will now receive a different concentration of CSF-1, subjects randomized to CSF-1 Component #1 will receive a different concentration of CSF-1 Component #1 and subjects randomized to CSF-1 Component #2 will continue dosing with the same concentration of CSF-1 Component #2. All subjects will continue dosing twice a day in both eyes for approximately 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSF-1 | Experimental | This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week. |
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| CSF-1 Component #1 | Active Comparator | This treatment arm consists of 2 different concentrations of CSF-1 Component #1. Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week. |
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| CSF-1 Component #2 | Active Comparator | This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSF-1 | Drug | This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm) | Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-Fixed Dose Combination (FDC) low dose (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone | 1 hour post dose on day 8 |
| Number of Subjects With ≥ 3 Lines Gain in BDCVA (at 40 cm) | Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.4% + diclofenac 0.006%) or pilocarpine HCl 0.4% alone or diclofenac 0.006% alone | 1 hour post dose on day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm) | Number of subjects with a ≥ 2-line gain in near BDCVA (at 40 cm0 at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone | 1 hour post dose on day 8 |
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Inclusion Criteria:
Subjects must:
Exclusion Criteria:
Subjects must not:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orasis Investigative Site | Newport Beach | California | 92660 | United States | ||
| Orasis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | CSF-1-FDC | pilocarpine HCl + diclofenac Na (fixed dose combination), 1 drop in each eye administered 2 times a day |
| FG001 | Pilo | pilocarpine HCl (alone), 1 drop in each eye administered 2 times a day |
| 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 | Jun 5, 2019 | Sep 16, 2022 |
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| CSF-1 Component #1 | Drug | This treatment arm consists of 2 different concentrations of CSF-1 Component #1. Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week. |
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| CSF-1 Component #2 | Drug | This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week. |
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| Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm) |
Number of subjects with a ≥ 2-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.4% + diclofenac 0.006%) or pilocarpine HCl 0.4% alone or diclofenac 0.006% alone |
| 1 hour post dose on day 15 |
| Littleton |
| Colorado |
| 80120 |
| United States |
| Orasis Investigative Site | Andover | Massachusetts | 01810 | United States |
| Orasis Investigative Site | Bloomington | Minnesota | 55420 | United States |
| Orasis Investigative Site | Cranberry Township | Pennsylvania | 16066 | United States |
| Orasis Investigative Site | Memphis | Tennessee | 38119 | United States |
| Orasis Investigative Site | Draper | Utah | 84020 | United States |
| FG002 | Diclo | diclofenac Na (serves as control group), 1 drop in each eye administered 2 times a day |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CSF-1-FDC | pilocarpine HCl + diclofenac Na (fixed dose combination) |
| BG001 | Pilo | pilocarpine HCl (alone) |
| BG002 | Diclo | diclofenac Na (serves as control group) |
| BG003 | 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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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm) | Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-Fixed Dose Combination (FDC) low dose (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone | The primary analysis was conducted on the per protocol (PP) study population set and therefore the number of subjects is slightly different than from the overall participant flow. | Posted | Count of Participants | Participants | 1 hour post dose on day 8 |
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| Primary | Number of Subjects With ≥ 3 Lines Gain in BDCVA (at 40 cm) | Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.4% + diclofenac 0.006%) or pilocarpine HCl 0.4% alone or diclofenac 0.006% alone | The primary analysis was conducted on the per protocol (PP) study population set and therefore the number of subjects is slightly different than from the overall participants flow. | Posted | Count of Participants | Participants | 1 hour post dose on day 15 |
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| Secondary | Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm) | Number of subjects with a ≥ 2-line gain in near BDCVA (at 40 cm0 at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone | The analysis was conducted on the per protocol (PP) study population set and therefore the number of subjects is slightly different than from the overall participants flow. | Posted | Count of Participants | Participants | 1 hour post dose on day 8 |
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| Secondary | Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm) | Number of subjects with a ≥ 2-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.4% + diclofenac 0.006%) or pilocarpine HCl 0.4% alone or diclofenac 0.006% alone | The analysis was conducted on the per protocol (PP) study population set and therefore the number of subjects is slightly different than from the overall participants flow. | Posted | Count of Participants | Participants | 1 hour post dose on day 15 |
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During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
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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-FDC | pilocarpine HCl + diclofenac Na (fixed dose combination) | 0 | 53 | 0 | 53 | 10 | 53 |
| EG001 | Pilo | pilocarpine HCl (alone) | 1 | 55 | 1 | 55 | 13 | 55 |
| EG002 | Diclo | diclofenac Na (serves as control group) | 0 | 58 | 0 | 58 | 6 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | Systematic Assessment | The subject experienced a non-ocular SAE of coronary artery disease which resulted in death. The SAE was severe and considered by the investigator to be not related to the study drug. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperemia | Eye disorders | Systematic Assessment |
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| Vision blurred | Eye disorders | Systematic Assessment |
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| Instillation site pain | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Regulatory Affairs | Orasis | +972-9-8877745 | iris.meisner@orasis-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2019 | Sep 16, 2022 | SAP_001.pdf |
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| 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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| 0.2660 |
| Odds Ratio (OR) |
| 1.646 |
| 2-Sided |
| 95 |
| 0.684 |
| 3.958 |
| Superiority |
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