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An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1) (NEAR-1)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04599933
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Orasis Pharmaceuticals Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Estimated Primary Completion Date : December 7, 2021
Estimated Study Completion Date : December 14, 2021

Arm Intervention/treatment
Experimental: CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
Drug: CSF-1
One drop bilaterally twice daily for approximately 2 weeks.

Placebo Comparator: Vehicle
One drop bilaterally twice daily for approximately 2 weeks.
Drug: Vehicle
One drop bilaterally twice daily for approximately 2 weeks.




Primary Outcome Measures :
  1. 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 :
  1. 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


Contacts
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Contact: Amy Baggeroer 978-409-5951 abaggeroer@oraclinical.com

Locations
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United States, Arizona
Orasis Investigative Site Recruiting
Sun City, Arizona, United States, 85351
United States, California
Orasis Investigative Site Recruiting
Glendale, California, United States, 91204
United States, Florida
Orasis Investigative Site Recruiting
Fort Myers, Florida, United States, 33901
Orasis Investigative Site Recruiting
Mount Dora, Florida, United States, 32757
United States, Georgia
Orasis Investigative Site Recruiting
Morrow, Georgia, United States, 30260
United States, Kansas
Orasis Investigative Site Recruiting
Overland Park, Kansas, United States, 66210
United States, Kentucky
Orasis Investigative Site Recruiting
Louisville, Kentucky, United States, 40206
United States, Missouri
Orasis Investigative Site Recruiting
Kansas City, Missouri, United States, 64133
Orasis Investigative Site Recruiting
Saint Louis, Missouri, United States, 63131
United States, Nevada
Orasis Investigative Site Recruiting
Henderson, Nevada, United States, 89052
United States, North Carolina
Orasis Investigative Site Recruiting
Elizabeth City, North Carolina, United States, 27909
United States, Pennsylvania
Orasis Investigative Site Recruiting
Cranberry Township, Pennsylvania, United States, 16066
Orasis Investigative Site Recruiting
Wilkes-Barre, Pennsylvania, United States, 18702
United States, South Dakota
Orasis Investigative Site Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Orasis Investigative Site Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Orasis Investigative Site Recruiting
El Paso, Texas, United States, 79902
Sponsors and Collaborators
Orasis Pharmaceuticals Ltd.
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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: August 9, 2021
Last Verified: October 2020

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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