A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia

PHASE2CompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

February 26, 2019

Primary Completion Date

July 11, 2019

Study Completion Date

July 26, 2019

Conditions
Presbyopia
Interventions
DRUG

CSF-1

This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.

DRUG

CSF-1 Component #1

"This treatment arm consists of 2 different concentrations of CSF-1 Component #1.~Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week."

DRUG

CSF-1 Component #2

This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week.

Trial Locations (7)

16066

Orasis Investigative Site, Cranberry Township

38119

Orasis Investigative Site, Memphis

55420

Orasis Investigative Site, Bloomington

80120

Orasis Investigative Site, Littleton

84020

Orasis Investigative Site, Draper

92660

Orasis Investigative Site, Newport Beach

01810

Orasis Investigative Site, Andover

Sponsors
All Listed Sponsors
lead

Orasis Pharmaceuticals Ltd.

INDUSTRY