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

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

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.

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.