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

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)

Sponsors

Lead Sponsor: Orasis Pharmaceuticals Ltd.

Source Orasis Pharmaceuticals Ltd.
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.

Overall Status Recruiting
Start Date October 26, 2020
Completion Date April 16, 2021
Primary Completion Date April 9, 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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. Day 8
Secondary Outcome
Measure Time Frame
Percentage of subjects with a ≥ 3-line gain in BDCVA at 40cm and no loss in BDCVA ≥ 5 letters at 4m. Day 1/Day 8/Day 15
Enrollment 300
Condition
Intervention

Intervention Type: Drug

Intervention Name: CSF-1

Description: One drop bilaterally twice daily for approximately 2 weeks.

Arm Group Label: CSF-1

Intervention Type: Drug

Intervention Name: Vehicle

Description: One drop bilaterally twice daily for approximately 2 weeks.

Arm Group Label: Vehicle

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.

Gender: All

Minimum Age: 45 Years

Maximum Age: 64 Years

Healthy Volunteers: No

Overall Contact

Last Name: Cam Dang

Phone: 949-800-9281

Email: [email protected]

Location
Facility: Status:
Orasis Investigative Site | Chandler, Arizona, 85225, United States Not yet recruiting
Orasis Investigative Site | Phoenix, Arizona, 85032, United States Not yet recruiting
Orasis Investigative Site | Garden Grove, California, 92843, United States Not yet recruiting
Orasis Investigative Site | Mission Hills, California, 91345, United States Not yet recruiting
Orasis Investigative Site | Newport Beach, California, 92663, United States Recruiting
Orasis Investigative Site | Rochester, New York, 14618, United States Not yet recruiting
Orasis Investigative Site | Kingston, Pennsylvania, 18704, United States Not yet recruiting
Orasis Investigative Site | Austin, Texas, 78731, United States Not yet recruiting
Orasis Investigative Site | Cedar Park, Texas, 78613, United States Not yet recruiting
Orasis Investigative Site | San Antonio, Texas, 78229, United States Not yet recruiting
Orasis Investigative Site | Draper, Utah, 84020, United States Recruiting
Orasis Investigative Site | Lynchburg, Virginia, 24502, United States Not yet recruiting
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: CSF-1

Type: Experimental

Description: One drop bilaterally twice daily for approximately 2 weeks.

Label: Vehicle

Type: Placebo Comparator

Description: One drop bilaterally twice daily for approximately 2 weeks.

Acronym NEAR-2
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov