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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05124275
• Other study ID #: ILUT-401-PRES
• Status: Completed
• Phase: Phase 2
• Start date: January 3, 2022
• Est. completion date: September 6, 2022

Study information

• Verified date: August 2023
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 1
• Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 2
• Pilocarpine Ophthalmic Topical Cream, Dose 3
Pilocarpine Ophthalmic Topical Cream, Dose 3
• Placebo Ophthalmic Topical Cream
Placebo Ophthalmic Topical Cream

Locations

Country	Name	City	State
United States	Glaukos Investigator	Chandler	Arizona
United States	Glaukos Investigator	Glendale	California
United States	Glaukos Investigator	Houston	Texas
United States	Glaukos Investigator	Louisville	Kentucky
United States	Glaukos Investigator	Memphis	Tennessee
United States	Glaukos Investigator	Newport Beach	California
United States	Glaukos Investigator	Petaluma	California
United States	Glaukos Investigator	Rochester	New York
United States	Glaukos Investigator	San Antonio	Texas
United States	Glaukos Investigator	Sun City	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular Distance Corrected Near Visual Acuity (DCNVA)	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.	Day 28
Secondary	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.	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