search
Back to results

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

Primary Purpose

Presbyopia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3
Placebo Ophthalmic Topical Cream
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Pilocarpine, Refractive errors, Loss of near vision

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Glaukos Investigator
  • Glaukos Investigator
  • Glaukos Investigator
  • Glaukos Investigator
  • Glaukos Investigator
  • Glaukos Investigator
  • Glaukos Investigator
  • Glaukos Investigator
  • Glaukos Investigator
  • Glaukos Investigator

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Pilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 3

Placebo Ophthalmic Topical Cream

Arm Description

Pilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 3

Placebo Ophthalmic Topical Cream

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 4, 2021
Last Updated
August 25, 2023
Sponsor
Glaukos Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT05124275
Brief Title
Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
September 6, 2022 (Actual)
Study Completion Date
September 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Pilocarpine, Refractive errors, Loss of near vision

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilocarpine Ophthalmic Topical Cream, Dose 1
Arm Type
Experimental
Arm Description
Pilocarpine Ophthalmic Topical Cream, Dose 1
Arm Title
Pilocarpine Ophthalmic Topical Cream, Dose 2
Arm Type
Experimental
Arm Description
Pilocarpine Ophthalmic Topical Cream, Dose 2
Arm Title
Pilocarpine Ophthalmic Topical Cream, Dose 3
Arm Type
Experimental
Arm Description
Pilocarpine Ophthalmic Topical Cream, Dose 3
Arm Title
Placebo Ophthalmic Topical Cream
Arm Type
Placebo Comparator
Arm Description
Placebo Ophthalmic Topical Cream
Intervention Type
Drug
Intervention Name(s)
Pilocarpine Ophthalmic Topical Cream, Dose 1
Other Intervention Name(s)
GLK-302
Intervention Description
Pilocarpine Ophthalmic Topical Cream, Dose 1
Intervention Type
Drug
Intervention Name(s)
Pilocarpine Ophthalmic Topical Cream, Dose 2
Other Intervention Name(s)
GLK-302
Intervention Description
Pilocarpine Ophthalmic Topical Cream, Dose 2
Intervention Type
Drug
Intervention Name(s)
Pilocarpine Ophthalmic Topical Cream, Dose 3
Other Intervention Name(s)
GLK-302
Intervention Description
Pilocarpine Ophthalmic Topical Cream, Dose 3
Intervention Type
Drug
Intervention Name(s)
Placebo Ophthalmic Topical Cream
Other Intervention Name(s)
Placebo
Intervention Description
Placebo Ophthalmic Topical Cream
Primary Outcome Measure Information:
Title
Binocular Distance Corrected Near Visual Acuity (DCNVA)
Description
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.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Glaukos Investigator
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Glaukos Investigator
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Glaukos Investigator
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Glaukos Investigator
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Glaukos Investigator
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Glaukos Investigator
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Glaukos Investigator
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Glaukos Investigator
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Glaukos Investigator
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Glaukos Investigator
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs