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An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2) (NEAR-2)

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: NCT04599972
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-2 Study: Near Eye-vision Acuity Restoration)
Actual Study Start Date : October 26, 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): NCT04599972


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
Chandler, Arizona, United States, 85225
Orasis Investigative Site Recruiting
Mesa, Arizona, United States, 85202
Orasis Investigative Site Recruiting
Phoenix, Arizona, United States, 85032
United States, California
Orasis Investigative Site Recruiting
Garden Grove, California, United States, 92843
Orasis Investigative Site Recruiting
Mission Hills, California, United States, 91345
Orasis Investigative Site Recruiting
Newport Beach, California, United States, 92663
Orasis Investigative Site Recruiting
Petaluma, California, United States, 94954
United States, Colorado
Orasis Investigative Site Recruiting
Littleton, Colorado, United States, 80120
United States, Connecticut
Orasis Investigative Site Recruiting
Danbury, Connecticut, United States, 06810
United States, Florida
Orasis Investigative Site Recruiting
Delray Beach, Florida, United States, 33484
United States, Illinois
Orasis Investigative Site Recruiting
Rock Island, Illinois, United States, 61201
United States, New York
Orasis Investigative Site Recruiting
Rochester, New York, United States, 14618
United States, Pennsylvania
Orasis Investigative Site Recruiting
Kingston, Pennsylvania, United States, 18704
United States, Texas
Orasis Investigative Site Withdrawn
Austin, Texas, United States, 78731
Orasis Investigative Site Recruiting
Cedar Park, Texas, United States, 78613
Orasis Investigative Site Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Orasis Investigative Site Recruiting
Clinton, Utah, United States, 84015
Orasis Investigative Site Recruiting
Draper, Utah, United States, 84020
United States, Virginia
Orasis Investigative Site Recruiting
Lynchburg, Virginia, United States, 24502
Sponsors and Collaborators
Orasis Pharmaceuticals Ltd.
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Responsible Party: Orasis Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT04599972    
Other Study ID Numbers: 20-150-0003
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