Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

NCT ID: NCT02188160

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-03-31

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).

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

KPI-121 0.25% Ophthalmic Suspension

KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease

Group Type: ACTIVE_COMPARATOR

KPI-121

Intervention Type: DRUG

KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.

Vehicle

Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.

Interventions

KPI-121

KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.

Intervention Type: DRUG

Placebo

Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.

Intervention Type: DRUG

Other Intervention Names

KPI-121 0.25% Ophthalmic Suspension; Loteprednol etabonate; Vehicle of KPI-121 0.25% Ophthalmic Suspension

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kala Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregg Berdy, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology Associates

David Evans, OD

Role: PRINCIPAL_INVESTIGATOR

Total Eye Care, PA

Kathy Kelley, OD

Role: PRINCIPAL_INVESTIGATOR

Price Vision Group

Joseph Martel, MD

Role: PRINCIPAL_INVESTIGATOR

Martel Eye Medical Group

Mark Milner, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Center of Southern CT, P.C.

Steven Rauchman, MD

Role: PRINCIPAL_INVESTIGATOR

North Valley Eye Medical Group

Kenneth Sall, MD

Role: PRINCIPAL_INVESTIGATOR

Sall Research Medical Center

Jeffrey Whitsett, MD

Role: PRINCIPAL_INVESTIGATOR

Whitsett Vision Group

Marc Abrams, MD

Role: PRINCIPAL_INVESTIGATOR

Abrams Eye Center

Michael Korenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Ecomprehensive Eye Care, Ltd / Vision Research Institute LLC

Jodi Luchs, MD

Role: PRINCIPAL_INVESTIGATOR

South Shore Eye Center

Locations

Sall Research Medical Center

Artesia, California, United States

North Valley Eye Medical Group

Mission Hills, California, United States

Martel Eye Medical Group

Rancho Cordova, California, United States

Eye Center of Southern CT, P.C.

Hamden, Connecticut, United States

Price Vision Group

Indianapolis, Indiana, United States

Ophthalmology Associates

St Louis, Missouri, United States

Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC

Washington, Missouri, United States

South Shore Eye Center, LLP

Wantagh, New York, United States

Abrams Eye Center

Cleveland, Ohio, United States

Total Eye Care, PA

Memphis, Tennessee, United States

Whitsett Vision Group

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32826644 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

KPI-121-C-002

Identifier Type: -

Identifier Source: org_study_id