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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
330
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days
Vehicle, one drop in each eye, once daily, for up to 30 days.
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
Time frame: Baseline (Day 1) to Day 30 (Hour 3)
Incidence and frequency of adverse events (AE) and serious adverse events (SAE) etc.
Time frame: Through study completion, an average of 60 days
Area under the plasma concentration time curve from time zero to the last measurable concentration(AUC0-t)
Time frame: Day 1 and Day 30
Area under the plasma concentration-time curve from time zero to infinity(AUC0-inf)
Time frame: Day 1 and Day 30
Maximum plasma concentration(Cmax)
Time frame: Day 1 and Day 30
Time to maximum plasma concentration (Tmax)
Time frame: Day 1 and Day 30
Apparent Volume of Distribution During Terminal Phase (Vz/F)
Time frame: Day 1 and Day 30
Apparent Terminal Elimination Half-Life (T1/2)
Time frame: Day 1 and Day 30
Apparent total body clearance (CL/F)
Time frame: Day 1 and Day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.