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

NCT06451666 | Not Yet Recruiting Phase 3

• 1 other identifier: SYH9042-001
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

Brief 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

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Pilocarpine HCl Ophthalmic Solution

EXPERIMENTAL

Drug: Pilocarpine HCl Ophthalmic Solution

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

Pilocarpine HCl Ophthalmic Solution DRUG

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

Pilocarpine HCl Ophthalmic Solution

Vehicle DRUG

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

Vehicle

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 40 to 65 years of age inclusive, at the time of the screening visit;
• 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;
• Mesopic, high contrast DCNVA of 20/40 to 20/100 in each eye at the screening and baseline visits;
• Photopic, high contrast, near visual acuity correctable to 20/40 or better in each eye at the screening and baseline visits;
• Dark adaptation pupil diameter between 4.0 mm and 8.0 mm in both eyes at the screening visit;
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

You may not qualify if:

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

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: For arm 1, patients received pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days. For arm 2, patients received vehicle, one drop in each eye, once daily, for up to 30 days.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 11, 2024
• Study Start: June 30, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-05