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

July 2, 2024 updated by: CSPC Ouyi Pharmaceutical Co., Ltd.

A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Pilocarpine HCl in Participants With Presbyopia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Clinical Trials Information Group officer
  • Phone Number: 86-0311-69085587
  • Email: ctr-contact@cspc.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1 Participant must be 40 to 65 years of age inclusive, at the time of the screening visit;
  • 2 Emmetropes or non-emmetropes with best distance correction in the range of spherical -4.00 D to +2.00 D inclusively and cylinder ±2.00 D with photopic, high contrast CDVA of 20/25 or better in each eye at the screening and baseline visits;
  • 3 Mesopic, high contrast DCNVA of 20/40 to 20/100 in each eye at the screening and baseline visits;
  • 4 Photopic, high contrast, near visual acuity correctable to 20/40 or better in each eye at the screening and baseline visits;
  • 5 Dark adaptation pupil diameter between 4.0 mm and 8.0 mm in both eyes at the screening visit;
  • 6 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

  • 1 Clinically significant disease state, in the opinion of the examining investigator or designee, in any body system;
  • 2 Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications;
  • 3 Any active ocular inflammation within 30 days prior to the first use of the investigational drug;
  • 4 Current enrollment in an study or participation in such a study within 30 days prior to the first use of the investigational drug;
  • 5 Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion;
  • 6 History of cataract surgery, phakic intraocular lens surgery, corneal refractive surgery, radial keratotomy, or any intraocular surgery;
  • 7 Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters;
  • 8 Moderate to severe dry eye disease at the screening visit;
  • 9 Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis at the screening visit;
  • 10 Diagnosis of any type of glaucoma or ocular hypertension;
  • 11 Female who have a positive pregnancy test during the screening period, lactating, or planning a pregnancy during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Vehicle
Drug: Vehicle
Vehicle, one drop in each eye, once daily, for up to 30 days.
Experimental: Pilocarpine HCl Ophthalmic Solution
Drug: Pilocarpine HCl Ophthalmic Solution
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Title: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3
Time Frame: Baseline (Day 1) to Day 30 (Hour 3)
Baseline (Day 1) to Day 30 (Hour 3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence and frequency of adverse events (AE) and serious adverse events (SAE) etc.
Time Frame: Through study completion, an average of 60 days
Through study completion, an average of 60 days
Area under the plasma concentration time curve from time zero to the last measurable concentration(AUC0-t)
Time Frame: Day 1 and Day 30
Day 1 and Day 30
Area under the plasma concentration-time curve from time zero to infinity(AUC0-inf)
Time Frame: Day 1 and Day 30
Day 1 and Day 30
Maximum plasma concentration(Cmax)
Time Frame: Day 1 and Day 30
Day 1 and Day 30
Time to maximum plasma concentration (Tmax)
Time Frame: Day 1 and Day 30
Day 1 and Day 30
Apparent Volume of Distribution During Terminal Phase (Vz/F)
Time Frame: Day 1 and Day 30
Day 1 and Day 30
Apparent Terminal Elimination Half-Life (T1/2)
Time Frame: Day 1 and Day 30
Day 1 and Day 30
Apparent total body clearance (CL/F)
Time Frame: Day 1 and Day 30
Day 1 and Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYH9042-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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