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Cholinergic Agonist

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

Phase 2
Waitlist Available
Research Sponsored by Glaukos Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28

Summary

This trial is testing a cream applied to the eyes called Pilocarpine for people who have trouble seeing things up close, a condition known as presbyopia. The cream works by making the pupils smaller, which helps improve near vision. The study aims to see if this treatment is safe and effective. Pilocarpine has been studied extensively for its potential in treating presbyopia, including its use in eye drops and other delivery methods.

Eligible Conditions
  • Presbyopia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Binocular Distance Corrected Near Visual Acuity (DCNVA)
Secondary study objectives
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.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Pilocarpine Ophthalmic Topical Cream, Dose 3Experimental Treatment1 Intervention
Pilocarpine Ophthalmic Topical Cream, Dose 3
Group II: Pilocarpine Ophthalmic Topical Cream, Dose 2Experimental Treatment1 Intervention
Pilocarpine Ophthalmic Topical Cream, Dose 2
Group III: Pilocarpine Ophthalmic Topical Cream, Dose 1Experimental Treatment1 Intervention
Pilocarpine Ophthalmic Topical Cream, Dose 1
Group IV: Placebo Ophthalmic Topical CreamPlacebo Group1 Intervention
Placebo Ophthalmic Topical Cream
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pilocarpine Ophthalmic Topical Cream, Dose 2
2022
Completed Phase 2
~350
Pilocarpine Ophthalmic Topical Cream, Dose 1
2022
Completed Phase 2
~350
Pilocarpine Ophthalmic Topical Cream, Dose 3
2022
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor
67 Previous Clinical Trials
9,215 Total Patients Enrolled
~31 spots leftby Dec 2025
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