Phase 2
Completed N=166
A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
Source: ClinicalTrials.gov NCT03885011 ↗Enrolled (actual)
166
Serious AEs
0.6%
Results posted
Jan 2023
Primary outcomePrimary: Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm) — 10; 12; 10 Participants — p=0.8445
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm) |
10; 12; 10 | 0.8445 |
| PRIMARY Number of Subjects With ≥ 3 Lines Gain in BDCVA (at 40 cm) |
22; 23; 9 | 0.0015 sig |
| SECONDARY Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm) |
35; 39; 24 | 0.0074 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
Data sourced from ClinicalTrials.gov (NCT03885011). 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.