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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119920
• Other study ID #: ILUT-401-DED
• Status: Completed
• Phase: Phase 2
• Start date: January 3, 2022
• Est. completion date: July 27, 2022

Study information

• Verified date: July 2023
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conjunctivitis
• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Kerato Conjunctivitis Sicca
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Glaukos Investigator	Chandler	Arizona
United States	Glaukos Investigator	Cranberry Township	Pennsylvania
United States	Glaukos Investigator	Fort Myers	Florida
United States	Glaukos Investigator	Glendale	California
United States	Glaukos Investigator	Grand Junction	Colorado
United States	Glaukos Investigator	Henderson	Nevada
United States	Glaukos Investigator	Houston	Texas
United States	Glaukos Investigator	Lynchburg	Virginia
United States	Glaukos Investigator	Memphis	Tennessee
United States	Glaukos Investigator	Mission Hills	California
United States	Glaukos Investigator	Nashville	Tennessee
United States	Glaukos Investigator	Newport Beach	California
United States	Glaukos Investigator	Petaluma	California
United States	Glaukos Investigator	Rancho Cordova	California
United States	Glaukos Investigator	Rochester	New York
United States	Glaukos Investigator	Roswell	Georgia
United States	Glaukos Investigator	Saint Louis	Missouri
United States	Glaukos Investigator	San Antonio	Texas
United States	Glaukos Investigator	Sun City	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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