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

NCT02188160 | Completed Phase 2 Results

• 1 other identifier: KPI-121-C-002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 11

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).

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Keywords

Pain; Corticosteroid; Dry Eye; Hyperemia; Ocular Discomfort

Outcome Measures

Primary Outcomes (2)

• Bulbar Conjunctival Hyperemia

  Comparison of mean bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.

  Visit 6 (Day 29)

• Ocular Discomfort

  Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.

  Visit 6 (Day 29)

Secondary Outcomes (3)

• Corneal Fluorescein Staining Scores

  Visit 4 (Day 15) and Visit 6 (Day 29)

• Bulbar Conjunctival Hyperemia Scores

  Visit 4 (Day 15)

• Ocular Discomfort

  Visit 4 (Day 15)

Study Arms (2)

KPI-121 0.25% Ophthalmic Suspension

ACTIVE COMPARATOR

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

Drug: KPI-121

Vehicle

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

KPI-121 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.

Also known as: KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonate

KPI-121 0.25% Ophthalmic Suspension

Placebo 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.

Also known as: Vehicle of KPI-121 0.25% Ophthalmic Suspension

Vehicle

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kala Pharmaceuticals, Inc.: lead

Study Sites (11)

Sall Research Medical Center

Artesia, California, 90701, United States

Location

North Valley Eye Medical Group

Mission Hills, California, 91345, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Eye Center of Southern CT, P.C.

Hamden, Connecticut, 06518, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

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

Washington, Missouri, 63090, United States

Location

South Shore Eye Center, LLP

Wantagh, New York, 11793, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

Related Publications (1)

• 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.

  PMID: 32826644 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pain; Hyperemia

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: VP, Clinical Development
• Organization: Kala Pharmaceuticals, Inc.

results002@kalarx.com

781-996-5252

Study Officials

• Gregg Berdy, MD

  Ophthalmology Associates

  PRINCIPAL INVESTIGATOR

• David Evans, OD

  Total Eye Care, PA

  PRINCIPAL INVESTIGATOR

• Kathy Kelley, OD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

• Joseph Martel, MD

  Martel Eye Medical Group

  PRINCIPAL INVESTIGATOR

• Mark Milner, MD

  Eye Center of Southern CT, P.C.

  PRINCIPAL INVESTIGATOR

• Steven Rauchman, MD

  North Valley Eye Medical Group

  PRINCIPAL INVESTIGATOR

• Kenneth Sall, MD

  Sall Research Medical Center

  PRINCIPAL INVESTIGATOR

• Jeffrey Whitsett, MD

  Whitsett Vision Group

  PRINCIPAL INVESTIGATOR

• Marc Abrams, MD

  Abrams Eye Center

  PRINCIPAL INVESTIGATOR

• Michael Korenfeld, MD

  Ecomprehensive Eye Care, Ltd / Vision Research Institute LLC

  PRINCIPAL INVESTIGATOR

• Jodi Luchs, MD

  South Shore Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: July 9, 2014
• First Posted: July 11, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 6, 2021
• Results First Posted: January 6, 2021

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)