Skip to main content
OpenTrials
Completed

NCT Number: NCT04599933

An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)

This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Orasis Investigative Site, Sun City, Arizona, United States

Loading trial locations.

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.

Treatment and study plan

CSF-1

Drug

One drop bilaterally twice daily for approximately 2 weeks.

Other names: pilocarpine HCl 0.4%

Vehicle

Drug

One drop bilaterally twice daily for approximately 2 weeks.

Primary outcomes

  1. Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1.

    Time frame: Baseline (Day 1) to Day 8 (1 hour post-Dose 1)

    The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment.

    A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m.

Secondary outcomes

  1. Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-Dose 1

    Time frame: Baseline (Day 1) to Day 8 (2 hours post-Dose 1)

    The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.

  2. Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2

    Time frame: Baseline (Day 1) to Day 8 (1 hour post-Dose 2; Dose 2 occurs 2 hours following Dose 1)

    The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.

  3. Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2

    Time frame: Baseline (Day 1) to Day 8 (2 hours post-Dose 2; Dose 2 occurs 2 hours following Dose 1)

    The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.

Sponsors and collaborators

Lead sponsor

Orasis Pharmaceuticals Ltd.

Industry

Registry information

Official study title

A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-1 Study: Near Eye-vision Acuity Restoration)

Acronym: NEAR-1

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2020
Registry last updated
Apr 4, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.