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

Launched by CSPC OUYI PHARMACEUTICAL CO., LTD. · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new eye drop solution called pilocarpine HCl to see how safe and effective it is for people with presbyopia, a common condition that makes it hard to see things up close as we age. The study will last for 30 days, and participants will use the eye drops once a day in both eyes. The goal is to find out if the drops can help improve vision for everyday tasks like reading.

To participate, individuals must be between 40 and 65 years old and have certain vision requirements, such as having good distance vision and some difficulty seeing up close. However, people with specific eye conditions, allergies to the medication, or a history of certain eye surgeries may not be eligible. Those who join the trial will have regular check-ups to monitor their vision and overall health during the month-long study. It's an opportunity to help researchers learn more about treating presbyopia, which could lead to better options for many people.

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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.