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Trial record 1 of 1 for:    NCT03885011
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A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia

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ClinicalTrials.gov Identifier: NCT03885011
Recruitment Status : Completed
First Posted : March 21, 2019
Results First Posted : January 26, 2023
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Orasis Pharmaceuticals Ltd.

Study Description
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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
Presbyopia 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
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Study Type : Interventional  (Clinical Trial)
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 : February 26, 2019
Actual Primary Completion Date : July 11, 2019
Actual Study Completion Date : July 26, 2019
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm) [ Time Frame: 1 hour post dose on day 8 ]
    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

  2. Number of Subjects With ≥ 3 Lines Gain in BDCVA (at 40 cm) [ Time Frame: 1 hour post dose on day 15 ]
    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


Secondary Outcome Measures :
  1. Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm) [ Time Frame: 1 hour post dose on day 8 ]
    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

  2. Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm) [ Time Frame: 1 hour post dose on day 15 ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885011


Locations
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United States, California
Orasis Investigative Site
Newport Beach, California, United States, 92660
United States, Colorado
Orasis Investigative Site
Littleton, Colorado, United States, 80120
United States, Massachusetts
Orasis Investigative Site
Andover, Massachusetts, United States, 01810
United States, Minnesota
Orasis Investigative Site
Bloomington, Minnesota, United States, 55420
United States, Pennsylvania
Orasis Investigative Site
Cranberry Township, Pennsylvania, United States, 16066
United States, Tennessee
Orasis Investigative Site
Memphis, Tennessee, United States, 38119
United States, Utah
Orasis Investigative Site
Draper, Utah, United States, 84020
Sponsors and Collaborators
Orasis Pharmaceuticals Ltd.
  Study Documents (Full-Text)

Documents provided by Orasis Pharmaceuticals Ltd.:
Study Protocol  [PDF] June 5, 2019
Statistical Analysis Plan  [PDF] July 24, 2019

More Information
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Responsible Party: Orasis Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03885011    
Other Study ID Numbers: 18-150-0006
First Posted: March 21, 2019    Key Record Dates
Results First Posted: January 26, 2023
Last Update Posted: January 26, 2023
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases