Phase 2 N=166 Randomized Double-blind Treatment

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

Presbyopia

Bottom Line

View on ClinicalTrials.gov: NCT03885011 ↗

Enrolled (actual)

166

Serious AEs

0.6%

Results posted

Jan 2023

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CSF-1 (Drug); CSF-1 Component #1 (Drug); CSF-1 Component #2 (Drug)
Age: Adult · 45+ yrs
Sex: All
Sponsor: Orasis Pharmaceuticals Ltd.
Primary completion: Jul 2019

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
SECONDARY Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)	35; 39; 24	0.0074 sig

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.

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

View full record on ClinicalTrials.gov →

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.