CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 304 enrolled
Drug / intervention
CSF-1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04599972
NCT04599972Phase 3Completed

A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-2 Study: Near Eye-vision Acuity Restoration)

Orasis Pharmaceuticals Ltd.·interventional·Posted Oct 23, 2020·Updated Apr 4, 2024

In Brief

A Phase 3 clinical trial evaluating CSF-1 and Vehicle for Presbyopia. Completed, enrolled 304 participants across 18 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPresbyopia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedOct 23, 2020
Enrollment StartOct 26, 2020
Primary CompletionJan 21, 2022
Study CompletionJan 28, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.7 years ago

Interventions

CSF-1drug

One drop bilaterally twice daily for approximately 2 weeks.

Vehicledrug

One drop bilaterally twice daily for approximately 2 weeks.