Clinical trial NCT02218489: Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
Official title: A Phase II, Double-Masked, Randomized, Vehicle-Controlled Study to Evaluate the Effect of KPI-121 0.25% Ophthalmic Suspension on Signs and Symptoms of Inflammatory Meibomian Gland Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blepharitis
Keywords: Pain
Corticosteroid
Meibomian Gland Disease
Blepharitis
Eyelid
Ocular Discomfort
Lead sponsor: Kala Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-18
Enrollment: 206
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: The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of inflammatory meibomian gland disease.

Detailed description: This is a Phase II, multicenter, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 ophthalmic suspension versus vehicle in subjects with signs and symptoms of inflammatory meibomian gland disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).

Eligibility criteria: Inclusion Criteria:

Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.

Exclusion Criteria:

* Known hypersensitivity/contraindication to study product(s) or components.
* Be currently receiving treatment for glaucoma, have history of or current glaucoma, or an IOP (intraocular pressure) over 21mmHg at Visit 1 (Screening) or Visit 2 (Randomization).
* Be unwilling to discontinue warm compress therapy, lid expression, or lid massage 14 days prior to Day 1 and for the duration of the study.
* Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening.
* Have had ocular surgery in the past 90 days or require ocular surgery during the study.
* In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Primary outcomes:
measure: Change From Baseline in Ocular Discomfort
timeFrame: Visit 2 (Day 1) to Visit 4 (Day 15)
measure: Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline
timeFrame: Visit 2 (Day 1) to Visit 4 (Day 15)
Secondary outcomes:
measure: Change From Baseline in Ocular Discomfort
timeFrame: Visit 2 (Day 1) to Visit 6 (Day 29)
measure: Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline
timeFrame: Visit 2 (Day 1) to Visit 6 (Day 29)
measure: Change From Baseline in Posterior Lid Margin Hyperemia
timeFrame: Visit 2 (Day 1) to Visit 4 (Day 15)
measure: Change From Baseline in Posterior Lid Margin Hyperemia
timeFrame: Visit 2 (Day 1) to Visit 6 (Day 29)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Optometry
state: Alabama
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Wantagh
country: United States
facility: South Shore Eye Center, LLP
state: New York
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Abrams Eye Center
name: Marc Abrams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wolstan & Goldberg Eye Associates
name: Damien Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Shore Eye Center, LLP
name: Jodi Luchs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UAB School of Optometry
name: Kelly Nichols, OD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Valley Eye Medical Group
name: Steven Rauchman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sall Research Medical Center
name: Kenneth Sall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Eye Consultants
name: John Sheppard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tauber Eye Center
name: Joseph Tauber, MD
role: PRINCIPAL_INVESTIGATOR
References: