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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1; Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2; Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3; Drug: Placebo Ophthalmic Topical Cream

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Glaukos Investigator
    • Sun City, Arizona, United States, 85351
      • Glaukos Investigator
  • California
    • Glendale, California, United States, 91204
      • Glaukos Investigator
    • Newport Beach, California, United States, 92663
      • Glaukos Investigator
    • Petaluma, California, United States, 94954
      • Glaukos Investigator
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Glaukos Investigator
  • New York
    • Rochester, New York, United States, 14618
      • Glaukos Investigator
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Glaukos Investigator
  • Texas
    • Houston, Texas, United States, 77025
      • Glaukos Investigator
    • San Antonio, Texas, United States, 78229
      • Glaukos Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilocarpine Ophthalmic Topical Cream, Dose 1	Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1; Pilocarpine Ophthalmic Topical Cream, Dose 1; Other Names: GLK-302
Experimental: Pilocarpine Ophthalmic Topical Cream, Dose 2	Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2; Pilocarpine Ophthalmic Topical Cream, Dose 2; Other Names: GLK-302
Experimental: Pilocarpine Ophthalmic Topical Cream, Dose 3	Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3; Pilocarpine Ophthalmic Topical Cream, Dose 3; Other Names: GLK-302
Placebo Comparator: Placebo Ophthalmic Topical Cream	Drug: Placebo Ophthalmic Topical Cream; Placebo Ophthalmic Topical Cream; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Glaukos Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pilocarpine; Refractive errors; Loss of near vision
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Miotics; Muscarinic Agonists; Pilocarpine
• Other Study ID Numbers: ILUT-401-PRES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No