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

CSPC Pharmaceutical Group

Status and phase

Not yet enrolling

Phase 3

Conditions

Presbyopia

Treatments

Drug: Vehicle

Drug: Pilocarpine HCl Ophthalmic Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT06451666

SYH9042-001

Details and patient eligibility

About

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.

Enrollment

330 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.