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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885011
• Other study ID #: 18-150-0006
• Status: Completed
• Phase: Phase 2
• Start date: February 26, 2019
• Est. completion date: July 26, 2019

Study information

• Verified date: September 2022
• Source: Orasis Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: July 26, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Orasis Investigative Site	Andover	Massachusetts
United States	Orasis Investigative Site	Bloomington	Minnesota
United States	Orasis Investigative Site	Cranberry Township	Pennsylvania
United States	Orasis Investigative Site	Draper	Utah
United States	Orasis Investigative Site	Littleton	Colorado
United States	Orasis Investigative Site	Memphis	Tennessee
United States	Orasis Investigative Site	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Orasis Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Subjects With = 2 Lines Gain in BDCVA (at 40 cm)	Number of subjects with a = 2-line gain in near BDCVA (at 40 cm0 at 1 hour post dose after 1 week treatment with CSF-1-FDC (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
Secondary	Number of Subjects With = 2 Lines Gain in BDCVA (at 40 cm)	Number of subjects with a = 2-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