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

Presbyopia Clinical Trial

— NEAR-1  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599933
• Other study ID #: 20-150-0002
• Status: Completed
• Phase: Phase 3
• Start date: October 18, 2020
• Est. completion date: February 19, 2022

Study information

• Verified date: October 2020
• 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: 309
• Est. completion date: February 19, 2022
• Est. primary completion date: February 11, 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	Cranberry Township	Pennsylvania
United States	Orasis Investigative Site	El Paso	Texas
United States	Orasis Investigative Site	Elizabeth City	North Carolina
United States	Orasis Investigative Site	Fort Myers	Florida
United States	Orasis Investigative Site	Glendale	California
United States	Orasis Investigative Site	Henderson	Nevada
United States	Orasis Investigative Site	Kansas City	Missouri
United States	Orasis Investigative Site	Los Angeles	California
United States	Orasis Investigative Site	Louisville	Kentucky
United States	Orasis Investigative Site	Memphis	Tennessee
United States	Orasis Investigative Site	Morrow	Georgia
United States	Orasis Investigative Site	Mount Dora	Florida
United States	Orasis Investigative Site	Overland Park	Kansas
United States	Orasis Investigative Site	Rapid City	South Dakota
United States	Orasis Investigative Site	Saint Louis	Missouri
United States	Orasis Investigative Site	Sun City	Arizona
United States	Orasis Investigative Site	Wilkes-Barre	Pennsylvania

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 on Day 8 at 2 Hours Post-Dose 1	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 occurs 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 occurs 2 hours following Dose 1)