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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451666
• Other study ID #: SYH9042-001
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: CSPC Ouyi Pharmaceutical Co., Ltd.
• Contact: Clinical Trials Information Group officer
• Phone: 86-0311-69085587
• Email: ctr-contact[@]cspc.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• Pilocarpine HCl Ophthalmic Solution
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days
• Vehicle
Vehicle, one drop in each eye, once daily, for up to 30 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSPC Ouyi Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence and frequency of adverse events (AE) and serious adverse events (SAE) etc.		Through study completion, an average of 60 days
Secondary	Area under the plasma concentration time curve from time zero to the last measurable concentration(AUC0-t)		Day 1 and Day 30
Secondary	Area under the plasma concentration-time curve from time zero to infinity(AUC0-inf)		Day 1 and Day 30
Secondary	Maximum plasma concentration(Cmax)		Day 1 and Day 30
Secondary	Time to maximum plasma concentration (Tmax)		Day 1 and Day 30
Secondary	Apparent Volume of Distribution During Terminal Phase (Vz/F)		Day 1 and Day 30
Secondary	Apparent Terminal Elimination Half-Life (T1/2)		Day 1 and Day 30
Secondary	Apparent total body clearance (CL/F)		Day 1 and Day 30