Clinical trial NCT02188160: Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Official title: A Phase II, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca
Keywords: Pain
Corticosteroid
Dry Eye
Hyperemia
Ocular Discomfort
Lead sponsor: Kala Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 150
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 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).

Detailed description: This is a Phase II, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

Approximately 400 subjects will be screened and up to 150 subjects will be randomized at up to 12 centers located in the United States. Subjects will be randomized to 1 of 2 study arms in an approximate 1:1 ratio. The study arms are: 1) KPI-121 0.25% ophthalmic suspension administered 1-2 drops in each eye QID for up to 28 days or 2) vehicle administered as 1-2 drops in each eye QID for up to 28 days.

This study will include up to 6 clinic visits over 6 weeks. At Visit 1 Screening (14 ± 1 days prior to Day 1), subjects who meet screening inclusion/exclusion criteria will begin a 2-week run-in period during which they will be treated with 1-2 drops of single-masked vehicle in each eye QID for 14 ± 1 days.

At Visit 2, Randomization (Day 1), subjects who continue to meet inclusion/exclusion criteria will be eligible for randomization to 1 of the 2 arms of the study (i.e., KPI-121 0.25% ophthalmic suspension or vehicle). Following randomization, subjects will be instructed to return to the clinic to have a complete study evaluation at Study Visits 4 and 6 (Days 15 ± 1 day and 29 ± 1 day, respectively). Subjects will further be instructed to return to the clinic for diary collection and in-clinic symptom assessment only at Visits 3 and 5 (Days 8 ± 1 day and 22 ± 1 day, respectively). The last dose of investigational product and the final study visit will occur upon completion of 28 ± 1 days of exposure to investigational product. Subjects will be released from the study at the end of Visit 6 (Day 29 ± 1 day).

Eligibility criteria: Inclusion Criteria:

• Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion Criteria:

* Known hypersensitivity/contraindication to study product(s) or components.
* History of glaucoma, IOP \>21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
* 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.
* 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: Bulbar Conjunctival Hyperemia
timeFrame: Visit 6 (Day 29)
measure: Ocular Discomfort
timeFrame: Visit 6 (Day 29)
Secondary outcomes:
measure: Corneal Fluorescein Staining Scores
timeFrame: Visit 4 (Day 15) and Visit 6 (Day 29)
measure: Bulbar Conjunctival Hyperemia Scores
timeFrame: Visit 4 (Day 15)
measure: Ocular Discomfort
timeFrame: Visit 4 (Day 15)
Other outcomes:
Locations:
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: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Hamden
country: United States
facility: Eye Center of Southern CT, P.C.
state: Connecticut
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
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: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
Study officials:
affiliation: Ophthalmology Associates
name: Gregg Berdy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Total Eye Care, PA
name: David Evans, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Price Vision Group
name: Kathy Kelley, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Martel Eye Medical Group
name: Joseph Martel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye Center of Southern CT, P.C.
name: Mark Milner, MD
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: Whitsett Vision Group
name: Jeffrey Whitsett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abrams Eye Center
name: Marc Abrams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ecomprehensive Eye Care, Ltd / Vision Research Institute LLC
name: Michael Korenfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Shore Eye Center
name: Jodi Luchs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korenfeld M, Nichols KK, Goldberg D, Evans D, Sall K, Foulks G, Coultas S, Brazzell K. Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies. Cornea. 2021 May 1;40(5):564-570. doi: 10.1097/ICO.0000000000002452.