Clinical trial NCT05119920: Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Kerato Conjunctivitis Sicca
Keywords: Dry eye syndromes
Eye diseases
Corneal diseases
Keratoconjunctivitis
Pilocarpine
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline in the VAS score at Day 28 visit.
timeFrame: Baseline and Day 28
measure: Mean change from baseline in Fluorescein Staining at the Day 28 visit.
timeFrame: Baseline and Day 28
Secondary outcomes:
measure: Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits
timeFrame: Baseline and Days 4, 8, and 14
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Glaukos Investigator
state: Arizona
city: Sun City
country: United States
facility: Glaukos Investigator
state: Arizona
city: Glendale
country: United States
facility: Glaukos Investigator
state: California
city: Mission Hills
country: United States
facility: Glaukos Investigator
state: California
city: Newport Beach
country: United States
facility: Glaukos Investigator
state: California
city: Petaluma
country: United States
facility: Glaukos Investigator
state: California
city: Rancho Cordova
country: United States
facility: Glaukos Investigator
state: California
city: Grand Junction
country: United States
facility: Glaukos Investigator
state: Colorado
city: Fort Myers
country: United States
facility: Glaukos Investigator
state: Florida
city: Roswell
country: United States
facility: Glaukos Investigator
state: Georgia
city: Saint Louis
country: United States
facility: Glaukos Investigator
state: Missouri
city: Henderson
country: United States
facility: Glaukos Investigator
state: Nevada
city: Rochester
country: United States
facility: Glaukos Investigator
state: New York
city: Cranberry Township
country: United States
facility: Glaukos Investigator
state: Pennsylvania
city: Memphis
country: United States
facility: Glaukos Investigator
state: Tennessee
city: Nashville
country: United States
facility: Glaukos Investigator
state: Tennessee
city: Houston
country: United States
facility: Glaukos Investigator
state: Texas
city: San Antonio
country: United States
facility: Glaukos Investigator
state: Texas
city: Lynchburg
country: United States
facility: Glaukos Investigator
state: Virginia
Study officials:
References: