NCT03885011

Brief Summary

This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

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

February 26, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2019

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 26, 2023

Completed
Last Updated

January 26, 2023

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

March 19, 2019

Results QC Date

September 16, 2022

Last Update Submit

January 3, 2023

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm)

    Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-Fixed Dose Combination (FDC) low dose (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone

    1 hour post dose on day 8

  • Number of Subjects With ≥ 3 Lines Gain in BDCVA (at 40 cm)

    Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.4% + diclofenac 0.006%) or pilocarpine HCl 0.4% alone or diclofenac 0.006% alone

    1 hour post dose on day 15

Secondary Outcomes (2)

  • Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)

    1 hour post dose on day 8

  • Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)

    1 hour post dose on day 15

Study Arms (3)

CSF-1

EXPERIMENTAL

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

CSF-1 Component #1

ACTIVE COMPARATOR

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 #1

CSF-1 Component #2

ACTIVE COMPARATOR

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.

Drug: CSF-1 Component #2

Interventions

CSF-1DRUG

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.

CSF-1
CSF-1 Component #1DRUG

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.

CSF-1 Component #1
CSF-1 Component #2DRUG

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.

CSF-1 Component #2

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must:
  • Have presbyopia

You may not qualify if:

  • Subjects must not:
  • 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 (7)

Orasis Investigative Site

Newport Beach, California, 92660, United States

Location

Orasis Investigative Site

Littleton, Colorado, 80120, United States

Location

Orasis Investigative Site

Andover, Massachusetts, 01810, United States

Location

Orasis Investigative Site

Bloomington, Minnesota, 55420, United States

Location

Orasis Investigative Site

Cranberry Township, Pennsylvania, 16066, United States

Location

Orasis Investigative Site

Memphis, Tennessee, 38119, United States

Location

Orasis Investigative Site

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Presbyopia

Interventions

Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Head of Regulatory Affairs
Organization
Orasis
iris.meisner@orasis-pharma.com
+972-9-8877745

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 21, 2019

Study Start

February 26, 2019

Primary Completion

July 11, 2019

Study Completion

July 26, 2019

Last Updated

January 26, 2023

Results First Posted

January 26, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(7)