NCT05124275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 3, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2022

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

November 4, 2021

Last Update Submit

August 25, 2023

Conditions

Presbyopia

Keywords

PilocarpineRefractive errorsLoss of near vision

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (4)

Pilocarpine Ophthalmic Topical Cream, Dose 1

EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 1

Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 2

EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 2

Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 3

EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 3

Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3

Placebo Ophthalmic Topical Cream

PLACEBO COMPARATOR

Placebo Ophthalmic Topical Cream

Drug: Placebo Ophthalmic Topical Cream

Interventions

Pilocarpine Ophthalmic Topical Cream, Dose 1DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 1

Also known as: GLK-302
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 2DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 2

Also known as: GLK-302
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 3

Also known as: GLK-302
Pilocarpine Ophthalmic Topical Cream, Dose 3
Placebo Ophthalmic Topical CreamDRUG

Placebo Ophthalmic Topical Cream

Also known as: Placebo
Placebo Ophthalmic Topical Cream

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Glaukos Investigator

Chandler, Arizona, 85224, United States

Location

Glaukos Investigator

Sun City, Arizona, 85351, United States

Location

Glaukos Investigator

Glendale, California, 91204, United States

Location

Glaukos Investigator

Newport Beach, California, 92663, United States

Location

Glaukos Investigator

Petaluma, California, 94954, United States

Location

Glaukos Investigator

Louisville, Kentucky, 40206, United States

Location

Glaukos Investigator

Rochester, New York, 14618, United States

Location

Glaukos Investigator

Memphis, Tennessee, 38119, United States

Location

Glaukos Investigator

Houston, Texas, 77025, United States

Location

Glaukos Investigator

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

PresbyopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2021

First Posted

November 17, 2021

Study Start

January 3, 2022

Primary Completion

September 6, 2022

Study Completion

September 6, 2022

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(10)