An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Safety of CSF-1 in Presbyopic Subjects
1 other identifier
interventional
178
1 country
12
Brief Summary
This is a multi-center, double-masked, vehicle-controlled study. The purpose of the study is to evaluate the safety of CSF-1 compared with vehicle in presbyopic subjects. Subjects will be treated for at least 6 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2022
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2022
CompletedFirst Submitted
Initial submission to the registry
May 10, 2022
CompletedFirst Posted
Study publicly available on registry
May 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedResults Posted
Study results publicly available
June 11, 2025
CompletedJune 11, 2025
December 1, 2022
7 months
May 10, 2022
October 30, 2024
June 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events.
As this is a safety study, no efficacy outcome has been defined.
Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
Study Arms (2)
CSF-1
EXPERIMENTALOne drop bilaterally twice daily for at least 6 weeks
Vehicle
PLACEBO COMPARATOROne drop bilaterally twice daily for at least 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have presbyopia
You may not qualify if:
- Have any contraindications to the study medications or diagnoses that would confound the study data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Orasis Investigative Site
Newport Beach, California, 92663, United States
Orasis Investigative Site
Petaluma, California, 94954, United States
Orasis Investigative Site
Colorado Springs, Colorado, 80907, United States
Orasis Investigative Site
Danbury, Connecticut, 06810, United States
Orasis Investigative Site
Rock Island, Illinois, 61201, United States
Orasis Investigative Site
Overland Park, Kansas, 66210, United States
Orasis Investigative Site
Elizabeth City, North Carolina, 27909, United States
Orasis Investigative Site
Fargo, North Dakota, 58103, United States
Orasis Investigative Site
Cranberry Township, Pennsylvania, 16066, United States
Orasis Investigative Site
Kingston, Pennsylvania, 18704, United States
Orasis Investigative Site
Memphis, Tennessee, 38119, United States
Orasis Investigative Site
Cedar Park, Texas, 78613, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Regulatory Affairs
- Organization
- Orasis Pharmaceuticals, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2022
First Posted
May 26, 2022
Study Start
April 22, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
June 11, 2025
Results First Posted
June 11, 2025
Record last verified: 2022-12