Clinical trial NCT04599933: An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Lead sponsor: Orasis Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 309
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 on Day 8 at 2 Hours Post-Dose 1
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 occurs 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 occurs 2 hours following Dose 1)
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Orasis Investigative Site
state: Arizona
city: Glendale
country: United States
facility: Orasis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Orasis Investigative Site
state: California
city: Fort Myers
country: United States
facility: Orasis Investigative Site
state: Florida
city: Mount Dora
country: United States
facility: Orasis Investigative Site
state: Florida
city: Morrow
country: United States
facility: Orasis Investigative Site
state: Georgia
city: Overland Park
country: United States
facility: Orasis Investigative Site
state: Kansas
city: Louisville
country: United States
facility: Orasis Investigative Site
state: Kentucky
city: Kansas City
country: United States
facility: Orasis Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Orasis Investigative Site
state: Missouri
city: Henderson
country: United States
facility: Orasis Investigative Site
state: Nevada
city: Elizabeth City
country: United States
facility: Orasis Investigative Site
state: North Carolina
city: Cranberry Township
country: United States
facility: Orasis Investigative Site
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Orasis Investigative Site
state: Pennsylvania
city: Rapid City
country: United States
facility: Orasis Investigative Site
state: South Dakota
city: Memphis
country: United States
facility: Orasis Investigative Site
state: Tennessee
city: El Paso
country: United States
facility: Orasis Investigative Site
state: Texas
Study officials:
References: