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

NCT ID: NCT06451666

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pilocarpine HCl Ophthalmic Solution

Group Type: EXPERIMENTAL

Pilocarpine HCl Ophthalmic Solution

Intervention Type: DRUG

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

Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

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

Interventions

Pilocarpine HCl Ophthalmic Solution

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

Intervention Type: DRUG

Vehicle

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

86-0311-69085587

Other Identifiers

SYH9042-001

Identifier Type: -

Identifier Source: org_study_id