Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia

Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream BID for the Treatment of Presbyopia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05124275

Enrollment

123

Registered

2021-11-17

Start date

2022-01-03

Completion date

2022-09-06

Last updated

2023-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Keywords

Pilocarpine, Refractive errors, Loss of near vision

Brief summary

This is a Multicenter, Randomized, Double-Masked Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia.

Interventions

DRUGPilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 1

DRUGPilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 2

DRUGPilocarpine Ophthalmic Topical Cream, Dose 3

Pilocarpine Ophthalmic Topical Cream, Dose 3

DRUGPlacebo Ophthalmic Topical Cream

Placebo Ophthalmic Topical Cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Presbyopic male or female 40-55 years of age * Willing and able to provide written informed consent on the IRB/IEC approved informed consent form

Exclusion criteria

* Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation * History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products * History of, or active, iritis or uveitis in either eye * Pre-existing retinal diseases in either eye that may pre-dispose the subjects to retinal detachment

Design outcomes

Primary

Measure	Time frame	Description
Binocular Distance Corrected Near Visual Acuity (DCNVA)	Day 28	Proportion of treatment responders \[subjects gaining 3 lines or more in binocular distance corrected near visual acuity (DCNVA) and not losing more than 5 letters of binocular best corrected distance visual acuity (BCDVA)\] 1 hour post-dose at the Day 28 visit.

Secondary

Measure	Time frame	Description
Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit.	Day 28	Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026