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

Sponsor
Orasis Pharmaceuticals Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03885011
Collaborator
(none)
166
7
3
4.9
23.7
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: CSF-1
  • Drug: CSF-1 Component #1
  • Drug: CSF-1 Component #2
Phase 2

Detailed Description

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. Approximately 150 subjects will be enrolled across 7 study centers in the United States. At Visit 2, subjects will be randomized 1:1:1 to one of three treatment arms: CSF-1, CSF-1 Component #1, or CSF-1 Component #2. All subjects will dose twice a day in both eyes with a single drop of their assigned treatment for approximately 1 week. At Visit 3, subjects randomized to CSF-1 will now receive a different concentration of CSF-1, subjects randomized to CSF-1 Component #1 will receive a different concentration of CSF-1 Component #1 and subjects randomized to CSF-1 Component #2 will continue dosing with the same concentration of CSF-1 Component #2. All subjects will continue dosing twice a day in both eyes for approximately 1 week.

Study Design

Study Type:
Interventional
Actual Enrollment :
166 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
Actual Study Start Date :
Feb 26, 2019
Actual Primary Completion Date :
Jul 11, 2019
Actual Study Completion Date :
Jul 26, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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
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.

Active Comparator: 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 #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.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in BCVA [Day 8/Day 15]

    Number of subjects with a >= 3-line gain in BCVA at various time points

Secondary Outcome Measures

  1. Change from baseline in BCVA [Day 8/Day 15]

    Number of subjects with a >= 2-line gain in BCVA at various time points

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subjects must:
  1. Have presbyopia
Exclusion Criteria:
  • Subjects must not:
  1. 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 92660
2 Orasis Investigative Site Littleton Colorado United States 80120
3 Orasis Investigative Site Andover Massachusetts United States 01810
4 Orasis Investigative Site Bloomington Minnesota United States 55420
5 Orasis Investigative Site Cranberry Township Pennsylvania United States 16066
6 Orasis Investigative Site Memphis Tennessee United States 38119
7 Orasis Investigative Site Draper Utah United States 84020

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:
NCT03885011
Other Study ID Numbers:
  • 18-150-0006
First Posted:
Mar 21, 2019
Last Update Posted:
Jul 21, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2020