Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 43 of 8757 for:    Eye AND Eye Diseases

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02188160
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

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).

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Keratoconjunctivitis Sicca Drug: KPI-121 Drug: Placebo Phase 2

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Active Comparator: KPI-121 0.25% Ophthalmic Suspension
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
Drug: 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.
Other Names:
  • KPI-121 0.25% Ophthalmic Suspension
  • Loteprednol etabonate

Placebo Comparator: Vehicle
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
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.
Other Name: Vehicle of KPI-121 0.25% Ophthalmic Suspension




Primary Outcome Measures :
  1. Bulbar Conjunctival Hyperemia [ Time Frame: Visit 6 ]
    Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group

  2. Ocular Discomfort [ Time Frame: Visits 5-6 ]
    Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188160


Locations
Layout table for location information
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
Martel Eye Medical Group
Rancho Cordova, California, United States, 95670
United States, Connecticut
Eye Center of Southern CT, P.C.
Hamden, Connecticut, United States, 06518
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
United States, Missouri
Ophthalmology Associates
Saint Louis, Missouri, United States, 63131
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
Washington, Missouri, United States, 63090
United States, New York
South Shore Eye Center, LLP
Wantagh, New York, United States, 11793
United States, Ohio
Abrams Eye Center
Cleveland, Ohio, United States, 44115
United States, Tennessee
Total Eye Care, PA
Memphis, Tennessee, United States, 38119
United States, Texas
Whitsett Vision Group
Houston, Texas, United States, 77055
Sponsors and Collaborators
Kala Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Principal Investigator: 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

Layout table for additonal information
Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02188160     History of Changes
Other Study ID Numbers: KPI-121-C-002
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kala Pharmaceuticals, Inc.:
Pain
Corticosteroid
Dry Eye
Hyperemia
Ocular Discomfort

Additional relevant MeSH terms:
Layout table for MeSH terms
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis Sicca
Keratoconjunctivitis
Conjunctivitis
Keratitis
Loteprednol Etabonate
Anti-Allergic Agents