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

NCT ID: NCT05119920

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2022-07-27

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye Disease Kerato Conjunctivitis Sicca

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 1

Group Type EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 1

Intervention Type DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 2

Group Type EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 2

Intervention Type DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 3

Pilocarpine Ophthalmic Topical Cream, Dose 3

Group Type EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 3

Intervention Type DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 3

Placebo Ophthalmic Topical Cream

Placebo Ophthalmic Topical Cream

Group Type PLACEBO_COMPARATOR

Placebo Ophthalmic Topical Cream

Intervention Type DRUG

Placebo Ophthalmic Topical Cream

Interventions

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Pilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 1

Intervention Type DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 2

Intervention Type DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 3

Pilocarpine Ophthalmic Topical Cream, Dose 3

Intervention Type DRUG

Placebo Ophthalmic Topical Cream

Placebo Ophthalmic Topical Cream

Intervention Type DRUG

Other Intervention Names

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GLK-301 GLK-301 GLK-301 Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Glaukos Investigator

Chandler, Arizona, United States

Site Status

Glaukos Investigator

Sun City, Arizona, United States

Site Status

Glaukos Investigator

Glendale, California, United States

Site Status

Glaukos Investigator

Mission Hills, California, United States

Site Status

Glaukos Investigator

Newport Beach, California, United States

Site Status

Glaukos Investigator

Petaluma, California, United States

Site Status

Glaukos Investigator

Rancho Cordova, California, United States

Site Status

Glaukos Investigator

Grand Junction, Colorado, United States

Site Status

Glaukos Investigator

Fort Myers, Florida, United States

Site Status

Glaukos Investigator

Roswell, Georgia, United States

Site Status

Glaukos Investigator

St Louis, Missouri, United States

Site Status

Glaukos Investigator

Henderson, Nevada, United States

Site Status

Glaukos Investigator

Rochester, New York, United States

Site Status

Glaukos Investigator

Cranberry Township, Pennsylvania, United States

Site Status

Glaukos Investigator

Memphis, Tennessee, United States

Site Status

Glaukos Investigator

Nashville, Tennessee, United States

Site Status

Glaukos Investigator

Houston, Texas, United States

Site Status

Glaukos Investigator

San Antonio, Texas, United States

Site Status

Glaukos Investigator

Lynchburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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ILUT-401-DED

Identifier Type: -

Identifier Source: org_study_id

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