Phase 3
Completed N=309
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
Source: ClinicalTrials.gov NCT04599933 ↗Enrolled (actual)
309
Serious AEs
0.3%
Results posted
Nov 2023
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
18citations · ~9 / year
Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials.
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.
Linked Publications
-
Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials.
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 |
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.
Data sourced from ClinicalTrials.gov (NCT04599933) and the linked publication. 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. Informational only — not medical advice.