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Safety and Efficacy Study of Pilocarpine HCl Ophthalmic Solution in Participants With Presbyopia

NCT06451666 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2024-07-03

No results posted yet for this study

Summary

A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine HCl ophthalmic solution when administered bilaterally, once daily for 30 days 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

DRUG

Vehicle

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

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-11-30
Completion
2025-12-30

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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 NCT06451666 on ClinicalTrials.gov