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

NCT05119920 | Completed Phase 2 FDA Drug

• 1 other identifier: ILUT-401-DED
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 19

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.

Conditions

Dry Eye Disease; Kerato Conjunctivitis Sicca

Keywords

Dry eye syndromes; Eye diseases; Corneal diseases; Keratoconjunctivitis; Pilocarpine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits

  Baseline and Days 4, 8, and 14

Study Arms (4)

Pilocarpine Ophthalmic Topical Cream, Dose 1

EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 1

Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 2

EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 2

Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 3

EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 3

Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3

Placebo Ophthalmic Topical Cream

PLACEBO COMPARATOR

Placebo Ophthalmic Topical Cream

Drug: Placebo Ophthalmic Topical Cream

Interventions

Pilocarpine Ophthalmic Topical Cream, Dose 1 DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 1

Also known as: GLK-301

Pilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 2 DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 2

Also known as: GLK-301

Pilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 3 DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 3

Also known as: GLK-301

Pilocarpine Ophthalmic Topical Cream, Dose 3

Placebo Ophthalmic Topical Cream DRUG

Placebo Ophthalmic Topical Cream

Also known as: Placebo

Placebo Ophthalmic Topical Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (19)

Glaukos Investigator

Chandler, Arizona, 85224, United States

Location

Glaukos Investigator

Sun City, Arizona, 85351, United States

Location

Glaukos Investigator

Glendale, California, 91204, United States

Location

Glaukos Investigator

Mission Hills, California, 91345, United States

Location

Glaukos Investigator

Newport Beach, California, 92663, United States

Location

Glaukos Investigator

Petaluma, California, 94954, United States

Location

Glaukos Investigator

Rancho Cordova, California, 95670, United States

Location

Glaukos Investigator

Grand Junction, Colorado, 81501, United States

Location

Glaukos Investigator

Fort Myers, Florida, 33901, United States

Location

Glaukos Investigator

Roswell, Georgia, 30076, United States

Location

Glaukos Investigator

St Louis, Missouri, 63131, United States

Location

Glaukos Investigator

Henderson, Nevada, 89052, United States

Location

Glaukos Investigator

Rochester, New York, 14618, United States

Location

Glaukos Investigator

Cranberry Township, Pennsylvania, 16066, United States

Location

Glaukos Investigator

Memphis, Tennessee, 38119, United States

Location

Glaukos Investigator

Nashville, Tennessee, 37215, United States

Location

Glaukos Investigator

Houston, Texas, 77025, United States

Location

Glaukos Investigator

San Antonio, Texas, 78229, United States

Location

Glaukos Investigator

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Eye Diseases; Corneal Diseases; Keratoconjunctivitis

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: January 3, 2022
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)