A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CSF-1 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. |
Drug: CSF-1
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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Active Comparator: CSF-1 Component #1 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. |
Drug: CSF-1 Component #1
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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Active Comparator: CSF-1 Component #2 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. |
Drug: CSF-1 Component #2
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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Outcome Measures
Primary Outcome Measures
- Change from baseline in BCVA [Day 8/Day 15]
Number of subjects with a >= 3-line gain in BCVA at various time points
Secondary Outcome Measures
- Change from baseline in BCVA [Day 8/Day 15]
Number of subjects with a >= 2-line gain in BCVA at various time points
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subjects must:
- Have presbyopia
Exclusion Criteria:
- Subjects must not:
- Have any contraindications to the study medications or diagnoses that would confound the study data
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Orasis Investigative Site | Newport Beach | California | United States | 92660 |
2 | Orasis Investigative Site | Littleton | Colorado | United States | 80120 |
3 | Orasis Investigative Site | Andover | Massachusetts | United States | 01810 |
4 | Orasis Investigative Site | Bloomington | Minnesota | United States | 55420 |
5 | Orasis Investigative Site | Cranberry Township | Pennsylvania | United States | 16066 |
6 | Orasis Investigative Site | Memphis | Tennessee | United States | 38119 |
7 | Orasis Investigative Site | Draper | Utah | United States | 84020 |
Sponsors and Collaborators
- Orasis Pharmaceuticals Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-150-0006