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A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

NCT03857542 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2021-12-29

Study results available
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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.

Conditions

Interventions

DRUG

Pilocarpine HCl Ophthalmic Solution

Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.

OTHER

Vehicle

Vehicle, one drop in each eye, once daily, for up to 30 days.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Eleonora Safyan · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-09-10
Completion
2020-09-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857542 on ClinicalTrials.gov