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Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease

Primary Purpose

Dry Eye Disease, Kerato Conjunctivitis Sicca

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 Dry Eye Disease focused on measuring Dry eye syndromes, Eye diseases, Corneal diseases, Keratoconjunctivitis, Pilocarpine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, 18 years of age or older at the Screening Visit
  • Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form
  • Diagnosis of dry eye

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 such as lotions, creams, makeup, soaps, etc.
  • History of, or active iritis or uveitis in either eye
  • Pre-existing retinal disease in either eye that may predispose 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
  • 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

Mean change from baseline in the VAS score at Day 28 visit.
Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
Mean change from baseline in Fluorescein Staining at the Day 28 visit.

Secondary Outcome Measures

Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits
Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)

Full Information

First Posted
November 3, 2021
Last Updated
July 6, 2023
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05119920
Brief Title
Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease
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 Signs and Symptoms of Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
July 27, 2022 (Actual)
Study Completion Date
July 27, 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 Signs and Symptoms of Dry Eye Disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease, Kerato Conjunctivitis Sicca
Keywords
Dry eye syndromes, Eye diseases, Corneal diseases, Keratoconjunctivitis, Pilocarpine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (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-301
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-301
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-301
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
Mean change from baseline in the VAS score at Day 28 visit.
Description
Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)
Time Frame
Baseline and Day 28
Title
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
Description
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
Time Frame
Baseline and Day 28
Secondary Outcome Measure Information:
Title
Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits
Description
Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)
Time Frame
Baseline and Days 4, 8, and 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, 18 years of age or older at the Screening Visit Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form Diagnosis of dry eye 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 such as lotions, creams, makeup, soaps, etc. History of, or active iritis or uveitis in either eye Pre-existing retinal disease in either eye that may predispose 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
Mission Hills
State/Province
California
ZIP/Postal Code
91345
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
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Glaukos Investigator
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Glaukos Investigator
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Glaukos Investigator
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Glaukos Investigator
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Glaukos Investigator
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
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
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Glaukos Investigator
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Glaukos Investigator
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
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
Facility Name
Glaukos Investigator
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
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 Dry Eye Disease

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