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

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: Not yet recruiting
• Conditions: Presbyopia
• Intervention / Treatment: Drug: Pilocarpine HCl Ophthalmic Solution; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 86-0311-69085587; Email: ctr-contact@cspc.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	Baseline (Day 1) to Day 30 (Hour 3)

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence and frequency of adverse events (AE) and serious adverse events (SAE) etc.	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)	Day 1 and Day 30
Area under the plasma concentration-time curve from time zero to infinity(AUC0-inf)	Day 1 and Day 30
Maximum plasma concentration(Cmax)	Day 1 and Day 30
Time to maximum plasma concentration (Tmax)	Day 1 and Day 30
Apparent Volume of Distribution During Terminal Phase (Vz/F)	Day 1 and Day 30
Apparent Terminal Elimination Half-Life (T1/2)	Day 1 and Day 30
Apparent total body clearance (CL/F)	Day 1 and Day 30

Collaborators and Investigators

• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Pharmaceutical Solutions; Miotics; Muscarinic Agonists; Ophthalmic Solutions; Pilocarpine
• Other Study ID 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