An Evaluation of the Long-Term Safety of CSF-1 in Presbyopic Subjects

• Sponsor: Orasis Pharmaceuticals Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05393895
• Collaborator: (none)
• Enrollment: 495
• Locations: 15
• Arms: 2
• Anticipated Duration (Months): 14.3
• Patients Per Site: 33
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

This is a 4 or 11 visit, multi-center, double-masked, vehicle-controlled study. The purpose of the study is to evaluate the long-term safety of CSF-1 compared with vehicle in presbyopic subjects.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Drug: CSF-1; Drug: Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 495 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Long-Term Safety of CSF-1 in Presbyopic Subjects
• Actual Study Start Date: Apr 22, 2022
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CSF-1 One drop bilaterally twice daily for approximately 52 weeks or 6 weeks	Drug: CSF-1; One drop bilaterally twice daily for approximately 52 weeks or 6 weeks
Placebo Comparator: Vehicle One drop bilaterally twice daily for approximately 52 weeks or 6 weeks	Drug: Vehicle; One drop bilaterally twice daily for approximately 52 weeks or 6 weeks

Outcome Measures

Primary Outcome Measures

1. Number of participants with treatment emergent adverse events. [Week 6 / Week 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have presbyopia

Exclusion Criteria:

• Have any contraindications to the study medications or diagnoses that would confound the study data

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orasis Investigative Site	Newport Beach	California	United States	92663
2	Orasis Investigative Site	Petaluma	California	United States	94954
3	Orasis Investigative Site	Santa Ana	California	United States	92705
4	Orasis Investigative Site	Colorado Springs	Colorado	United States	80907
5	Orasis Investigative Site	Littleton	Colorado	United States	80120
6	Orasis Investigative Site	Danbury	Connecticut	United States	06810
7	Orasis Investigative Site	Melbourne	Florida	United States	32901
8	Orasis Investigative Site	Mount Dora	Florida	United States	32757
9	Orasis Investigative Site	Rock Island	Illinois	United States	61201
10	Orasis Investigative Site	Overland Park	Kansas	United States	66210
11	Orasis Investigative Site	Elizabeth City	North Carolina	United States	27909
12	Orasis Investigative Site	Cranberry Township	Pennsylvania	United States	16066
13	Orasis Investigative Site	Kingston	Pennsylvania	United States	18704
14	Orasis Investigative Site	Memphis	Tennessee	United States	38119
15	Orasis Investigative Site	Cedar Park	Texas	United States	78613

Sponsors and Collaborators

• Orasis Pharmaceuticals Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orasis Pharmaceuticals Ltd.
• ClinicalTrials.gov Identifier: NCT05393895
• Other Study ID Numbers: 21-150-0005
• First Posted: May 26, 2022
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Presbyopia

Study Results

No Results Posted as of Jun 23, 2022