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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease; Kerato Conjunctivitis Sicca
• 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): 226
• 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
    • Mission Hills, California, United States, 91345
      • Glaukos Investigator
    • Newport Beach, California, United States, 92663
      • Glaukos Investigator
    • Petaluma, California, United States, 94954
      • Glaukos Investigator
    • Rancho Cordova, California, United States, 95670
      • Glaukos Investigator
  • Colorado
    • Grand Junction, Colorado, United States, 81501
      • Glaukos Investigator
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Glaukos Investigator
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Glaukos Investigator
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Glaukos Investigator
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Glaukos Investigator
  • New York
    • Rochester, New York, United States, 14618
      • Glaukos Investigator
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Glaukos Investigator
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Glaukos Investigator
    • Nashville, Tennessee, United States, 37215
      • Glaukos Investigator
  • Texas
    • Houston, Texas, United States, 77025
      • Glaukos Investigator
    • San Antonio, Texas, United States, 78229
      • Glaukos Investigator
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Glaukos Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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-301
Experimental: Pilocarpine Ophthalmic Topical Cream, Dose 2	Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2; Pilocarpine Ophthalmic Topical Cream, Dose 2; Other Names: GLK-301
Experimental: Pilocarpine Ophthalmic Topical Cream, Dose 3	Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3; Pilocarpine Ophthalmic Topical Cream, Dose 3; Other Names: GLK-301
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
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)	Baseline and Day 28
Mean change from baseline in Fluorescein Staining at the Day 28 visit.	Mean change from baseline in Fluorescein Staining at the Day 28 visit.	Baseline and Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and Days 4, 8, and 14

Collaborators and Investigators

• Sponsor: Glaukos Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Eye diseases; Dry eye syndromes; Pilocarpine; Corneal diseases; Keratoconjunctivitis
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Conjunctivitis; Keratoconjunctivitis; 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-DED

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