Clinical trial NCT04599972: An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Lead sponsor: Orasis Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 304
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline (Day 1) to Day 8 (1 hour post-Dose 1)
Secondary outcomes:
measure: Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m.
timeFrame: Baseline (Day 1) to Day 8 (2 hours post-Dose 1)
measure: 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
timeFrame: Baseline (Day 1) to Day 8 (1 hour post Dose 2; Dose 2 occurred 2 hours following Dose 1)
measure: 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
timeFrame: Baseline (Day 1) to Day 8 (2 hours post Dose 2; Dose 2 occurred 2 hours following Dose 1)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Orasis Investigative Site
state: Arizona
city: Mesa
country: United States
facility: Orasis Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Orasis Investigative Site
state: Arizona
city: Garden Grove
country: United States
facility: Orasis Investigative Site
state: California
city: Mission Hills
country: United States
facility: Orasis Investigative Site
state: California
city: Newport Beach
country: United States
facility: Orasis Investigative Site
state: California
city: Petaluma
country: United States
facility: Orasis Investigative Site
state: California
city: Littleton
country: United States
facility: Orasis Investigative Site
state: Colorado
city: Danbury
country: United States
facility: Orasis Investigative Site
state: Connecticut
city: Delray Beach
country: United States
facility: Orasis Investigative Site
state: Florida
city: Rock Island
country: United States
facility: Orasis Investigative Site
state: Illinois
city: Rochester
country: United States
facility: Orasis Investigative Site
state: New York
city: Kingston
country: United States
facility: Orasis Investigative Site
state: Pennsylvania
city: Cedar Park
country: United States
facility: Orasis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Orasis Investigative Site
state: Texas
city: Clinton
country: United States
facility: Orasis Investigative Site
state: Utah
city: Draper
country: United States
facility: Orasis Investigative Site
state: Utah
city: Lynchburg
country: United States
facility: Orasis Investigative Site
state: Virginia
Study officials:
References: