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
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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COMPLETED
PHASE2
226 participants
INTERVENTIONAL
2022-01-03
2022-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3
Pilocarpine Ophthalmic Topical Cream, Dose 3
Pilocarpine Ophthalmic Topical Cream, Dose 3
Pilocarpine Ophthalmic Topical Cream, Dose 3
Placebo Ophthalmic Topical Cream
Placebo Ophthalmic Topical Cream
Placebo Ophthalmic Topical Cream
Placebo Ophthalmic Topical Cream
Interventions
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Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3
Pilocarpine Ophthalmic Topical Cream, Dose 3
Placebo Ophthalmic Topical Cream
Placebo Ophthalmic Topical Cream
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form
* Diagnosis of dry eye
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Glaukos Corporation
INDUSTRY
Responsible Party
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Locations
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Glaukos Investigator
Chandler, Arizona, United States
Glaukos Investigator
Sun City, Arizona, United States
Glaukos Investigator
Glendale, California, United States
Glaukos Investigator
Mission Hills, California, United States
Glaukos Investigator
Newport Beach, California, United States
Glaukos Investigator
Petaluma, California, United States
Glaukos Investigator
Rancho Cordova, California, United States
Glaukos Investigator
Grand Junction, Colorado, United States
Glaukos Investigator
Fort Myers, Florida, United States
Glaukos Investigator
Roswell, Georgia, United States
Glaukos Investigator
St Louis, Missouri, United States
Glaukos Investigator
Henderson, Nevada, United States
Glaukos Investigator
Rochester, New York, United States
Glaukos Investigator
Cranberry Township, Pennsylvania, United States
Glaukos Investigator
Memphis, Tennessee, United States
Glaukos Investigator
Nashville, Tennessee, United States
Glaukos Investigator
Houston, Texas, United States
Glaukos Investigator
San Antonio, Texas, United States
Glaukos Investigator
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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ILUT-401-DED
Identifier Type: -
Identifier Source: org_study_id
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