Phase 3 N=309 Randomized Double-blind Treatment

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

Presbyopia

Bottom Line

View on ClinicalTrials.gov: NCT04599933 ↗

Enrolled (actual)

309

Serious AEs

0.3%

Results posted

Nov 2023

Primary outcome: Primary: 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. — 60; 26 Participants — p=<0.01

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: CSF-1 (Drug); Vehicle (Drug)
Age: Adult · 45+ yrs
Sex: All
Sponsor: Orasis Pharmaceuticals Ltd.
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	60; 26	<0.01 sig
SECONDARY 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	61; 26	<0.01 sig
SECONDARY 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	74; 24	<0.01 sig
SECONDARY 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	60; 23	<0.01 sig

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04599933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.