NCT06451666Not yet recruitingPhase 3
A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Pilocarpine HCl in Participants With Presbyopia
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 330
- Primary Endpoint
- 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
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Pilocarpine HCl Ophthalmic Solution
Experimental
Intervention: Pilocarpine HCl Ophthalmic Solution (Drug)
Vehicle
Placebo Comparator
Intervention: Vehicle (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Incidence and frequency of adverse events (AE) and serious adverse events (SAE) etc.(Through study completion, an average of 60 days)
- Maximum plasma concentration(Cmax)(Day 1 and Day 30)
- Apparent Volume of Distribution During Terminal Phase (Vz/F)(Day 1 and Day 30)
- Apparent Terminal Elimination Half-Life (T1/2)(Day 1 and Day 30)
- Area under the plasma concentration time curve from time zero to the last measurable concentration(AUC0-t)(Day 1 and Day 30)
- Area under the plasma concentration-time curve from time zero to infinity(AUC0-inf)(Day 1 and Day 30)
- Time to maximum plasma concentration (Tmax)(Day 1 and Day 30)
- Apparent total body clearance (CL/F)(Day 1 and Day 30)
Investigators
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