At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 323 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 Vehicle and Pilocarpine HCl Ophthalmic Solution for Presbyopia. Completed, enrolled 323 participants across 36 sites.
Detailed Summary
A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPresbyopia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartDec 2018
First PostedJan 2019
Primary CompletionOct 2019
TodayJul 2026
First PostedJan 15, 2019
Enrollment StartDec 21, 2018
Primary CompletionOct 31, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.5 years ago
Interventions
Vehicleother
Vehicle, one drop in each eye, once daily, for up to 30 days.
Pilocarpine HCl Ophthalmic Solutiondrug
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.