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Completed

NCT Number: NCT03885011

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

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Orasis Investigative Site, Newport Beach, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must:
  • Have presbyopia

Exclusion criteria

  • Subjects must not:
  • Have any contraindications to the study medications or diagnoses that would confound the study data

Treatment and study plan

CSF-1

Drug

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

Drug

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

Drug

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Orasis Pharmaceuticals Ltd.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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