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

Phase 2

Completed

• Conditions: Presbyopia
• Interventions: Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2; Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3; Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1; Drug: Placebo Ophthalmic Topical Cream

• Registration Number: NCT05124275
• Lead Sponsor: Glaukos Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-17
• Study Start: 2022-01-03
• Primary Completion: 2022-09-06
• Study Completion: 2022-09-06
• Status Verified: 2023-08
• Disposition First Submitted: 2023-08-25
• Last Update Submitted: 2023-08-25
• Disposition First Posted: 2023-09-01
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilocarpine Ophthalmic Topical Cream, Dose 2	Pilocarpine Ophthalmic Topical Cream, Dose 2	Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3	Pilocarpine Ophthalmic Topical Cream, Dose 3	Pilocarpine Ophthalmic Topical Cream, Dose 3
Pilocarpine Ophthalmic Topical Cream, Dose 1	Pilocarpine Ophthalmic Topical Cream, Dose 1	Pilocarpine Ophthalmic Topical Cream, Dose 1
Placebo Ophthalmic Topical Cream	Placebo Ophthalmic Topical Cream	Placebo Ophthalmic Topical Cream

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Glaukos Investigator; 🇺🇸 San Antonio, Texas, United States