At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 427 enrolled
Drug / intervention
Pilocarpine HCl Ophthalmic Solution +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.
A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia
In Brief
A Phase 3 clinical trial evaluating Pilocarpine HCl Ophthalmic Solution and Vehicle for Presbyopia. Completed, enrolled 427 participants across 35 sites.
Detailed Summary
This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution (AGN-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once daily bilaterally in participants with presbyopia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPresbyopia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartMar 2019
Primary CompletionSep 2020
TodayJul 2026
First PostedFeb 28, 2019
Enrollment StartMar 1, 2019
Primary CompletionSep 10, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.3 years ago
Interventions
Pilocarpine HCl Ophthalmic Solutiondrug
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
Vehicleother
Vehicle, one drop in each eye, once daily, for up to 30 days.