CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 166 enrolled
Drug / intervention
CSF-1 +2 moredrug
Likely dose
CSF-1 ophthalmic solution, twice daily in both eyes with a single drop for approximately 1 weekAI-extracted
Key inclusion· 1
  • ✓Diagnosis of presbyopia
Key exclusion· 1
  • ✕Contraindications to study medications or diagnoses that would confound study data

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

Search/NCT03885011
NCT03885011Phase 2Completed
CompareCT.gov

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

Orasis Pharmaceuticals Ltd.·interventional·Posted Mar 21, 2019·Updated Jan 26, 2023

In Brief

A Phase 2 clinical trial evaluating CSF-1, CSF-1 Component #1, and 1 other intervention for Presbyopia. Completed, enrolled 166 participants across 7 sites.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartFeb 26, 2019
Primary CompletionJul 11, 2019
Study CompletionJul 26, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.3 years ago

Interventions

CSF-1drug

This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.

CSF-1 Component #1drug

This treatment arm consists of 2 different concentrations of CSF-1 Component #1. Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.

CSF-1 Component #2drug

This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week.