An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1) (NEAR-1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04599933 |
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Recruitment Status :
Completed
First Posted : October 23, 2020
Last Update Posted : January 12, 2023
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Sponsor:
Orasis Pharmaceuticals Ltd.
Information provided by (Responsible Party):
Orasis Pharmaceuticals Ltd.
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Presbyopia | Drug: CSF-1 Drug: Vehicle | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 309 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-1 Study: Near Eye-vision Acuity Restoration) |
| Actual Study Start Date : | October 19, 2020 |
| Actual Primary Completion Date : | February 11, 2022 |
| Actual Study Completion Date : | February 18, 2022 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Pilocarpine
| Arm | Intervention/treatment |
|---|---|
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Experimental: CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
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Drug: CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
Other Name: pilocarpine HCl 0.4% |
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Placebo Comparator: Vehicle
One drop bilaterally twice daily for approximately 2 weeks.
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Drug: Vehicle
One drop bilaterally twice daily for approximately 2 weeks. |
Primary Outcome Measures :
- 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. [ Time Frame: Day 8 ]
Secondary Outcome Measures :
- Percentage of subjects with a ≥ 3-line gain in BDCVA at 40cm and no loss in BDCVA ≥ 5 letters at 4m. [ Time Frame: Day 1/Day 8/Day 15 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 45 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599933
Locations
| United States, Arizona | |
| Orasis Investigative Site | |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| Orasis Investigative Site | |
| Glendale, California, United States, 91204 | |
| Orasis Investigative Site | |
| Los Angeles, California, United States, 90013 | |
| United States, Florida | |
| Orasis Investigative Site | |
| Fort Myers, Florida, United States, 33901 | |
| Orasis Investigative Site | |
| Mount Dora, Florida, United States, 32757 | |
| United States, Georgia | |
| Orasis Investigative Site | |
| Morrow, Georgia, United States, 30260 | |
| United States, Kansas | |
| Orasis Investigative Site | |
| Overland Park, Kansas, United States, 66210 | |
| United States, Kentucky | |
| Orasis Investigative Site | |
| Louisville, Kentucky, United States, 40206 | |
| United States, Missouri | |
| Orasis Investigative Site | |
| Kansas City, Missouri, United States, 64133 | |
| Orasis Investigative Site | |
| Saint Louis, Missouri, United States, 63131 | |
| United States, Nevada | |
| Orasis Investigative Site | |
| Henderson, Nevada, United States, 89052 | |
| United States, North Carolina | |
| Orasis Investigative Site | |
| Elizabeth City, North Carolina, United States, 27909 | |
| United States, Pennsylvania | |
| Orasis Investigative Site | |
| Cranberry Township, Pennsylvania, United States, 16066 | |
| Orasis Investigative Site | |
| Wilkes-Barre, Pennsylvania, United States, 18702 | |
| United States, South Dakota | |
| Orasis Investigative Site | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| Orasis Investigative Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Orasis Investigative Site | |
| El Paso, Texas, United States, 79902 | |
Sponsors and Collaborators
Orasis Pharmaceuticals Ltd.
| Responsible Party: | Orasis Pharmaceuticals Ltd. |
| ClinicalTrials.gov Identifier: | NCT04599933 |
| Other Study ID Numbers: |
20-150-0002 |
| First Posted: | October 23, 2020 Key Record Dates |
| Last Update Posted: | January 12, 2023 |
| Last Verified: | October 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Presbyopia Refractive Errors Eye Diseases Pilocarpine Miotics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Muscarinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |