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

Phase 2

Completed

• Conditions: Kerato Conjunctivitis Sicca; Dry Eye Disease
• Interventions: Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1; Drug: Placebo Ophthalmic Topical Cream; Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2; Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3

• Registration Number: NCT05119920
• Lead Sponsor: Glaukos Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Study Start: 2022-01-03
• Primary Completion: 2022-07-27
• Study Completion: 2022-07-27
• Status Verified: 2023-07
• Disposition First Submitted: 2023-07-06
• Last Update Submitted: 2023-07-06
• Disposition First Posted: 2023-07-12
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilocarpine Ophthalmic Topical Cream, Dose 1	Pilocarpine Ophthalmic Topical Cream, Dose 1	Pilocarpine Ophthalmic Topical Cream, Dose 1
Placebo Ophthalmic Topical Cream	Placebo Ophthalmic Topical Cream	Placebo Ophthalmic Topical Cream
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

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in the VAS score at Day 28 visit.	Baseline and Day 28	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.	Baseline and Day 28	Mean change from baseline in Fluorescein Staining at the Day 28 visit.

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits	Baseline and Days 4, 8, and 14	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)

Trial Locations

Locations (1)

Glaukos Investigator; 🇺🇸 Lynchburg, Virginia, United States