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

Presbyopia Clinical Trial

— NEAR-2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599972
• Other study ID #: 20-150-0003
• Status: Completed
• Phase: Phase 3
• Start date: October 26, 2020
• Est. completion date: January 28, 2022

Study information

• Verified date: November 2023
• Source: Orasis Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: January 28, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
• Vehicle
One drop bilaterally twice daily for approximately 2 weeks.

Locations

Country	Name	City	State
United States	Orasis Investigative Site	Cedar Park	Texas
United States	Orasis Investigative Site	Chandler	Arizona
United States	Orasis Investigative Site	Clinton	Utah
United States	Orasis Investigative Site	Danbury	Connecticut
United States	Orasis Investigative Site	Delray Beach	Florida
United States	Orasis Investigative Site	Draper	Utah
United States	Orasis Investigative Site	Garden Grove	California
United States	Orasis Investigative Site	Kingston	Pennsylvania
United States	Orasis Investigative Site	Littleton	Colorado
United States	Orasis Investigative Site	Lynchburg	Virginia
United States	Orasis Investigative Site	Mesa	Arizona
United States	Orasis Investigative Site	Mission Hills	California
United States	Orasis Investigative Site	Newport Beach	California
United States	Orasis Investigative Site	Petaluma	California
United States	Orasis Investigative Site	Phoenix	Arizona
United States	Orasis Investigative Site	Rochester	New York
United States	Orasis Investigative Site	Rock Island	Illinois
United States	Orasis Investigative Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Orasis Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 on Day 8, 1 Hour Post-Dose 1.	The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment.; A responder was defined as as subject with a = 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA = 5 letters at 4m.	Baseline (Day 1) to Day 8 (1 hour post-Dose 1)
Secondary	Percentage of Subjects With a = 3-line Gain in BDCVA at 40cm and no Loss in BDCVA = 5 Letters at 4m.	The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a = 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA = 5 letters (ETDRS chart at 4 m) in the study eye.	Baseline (Day 1) to Day 8 (2 hours post-Dose 1)
Secondary	Percentage of Subjects With a = 3-line Gain in BDCVA at 40cm and no Loss in BDCVA = 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2	The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a = 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA = 5 letters (ETDRS chart at 4 m) in the study eye.	Baseline (Day 1) to Day 8 (1 hour post Dose 2; Dose 2 occurred 2 hours following Dose 1)
Secondary	Percentage of Subjects With a = 3-line Gain in BDCVA at 40cm and no Loss in BDCVA = 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2	The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a = 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA = 5 letters (ETDRS chart at 4 m) in the study eye.	Baseline (Day 1) to Day 8 (2 hours post Dose 2; Dose 2 occurred 2 hours following Dose 1)