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Dry Eye SyndromesPhase 3STRIDE 2NCT02819284

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

A Phase 3 study testing KPI-121 0.25% Ophthalmic Suspension in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Kala Pharmaceuticals, Inc. at 62 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 14 days, with 1-2 drops instilled in each eye four times daily (QID). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Syndromes, Keratoconjunctivitis Sicca
What is being tested?
KPI-121 0.25% Ophthalmic Suspension
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
909 participants
Where
62 sitesUnited States
Study dates
Jun 2016to Sep 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Known hypersensitivity or contraindication to the investigational 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; or have been exposed to an investigational drug within 30 days prior to screening.
  • In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Trial locations and contacts

62 sites in 1 country.

62 sites in 1 country

United States62 sites

  • Sall Research Medical Center

    Artesia, California, 90701

  • Texan Eye, PA / Keystone Research, Ltd

    Austin, Texas, 78731

  • Milton M. Hom, OD, FAAO

    Azusa, California, 91702

  • UAB School of Optometry

    Birmingham, Alabama, 35294-0010

  • Minnesota Eye Consultants, PA

    Bloomington, Minnesota, 55431

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Hernando Eye Institute

    Brooksville, Florida, 34613

  • Family Eye Care Center

    Campbell, California, 95008

  • Arizona Eye Center

    Chandler, Arizona, 85225

  • Chattanooga Eye Institute, P.C.

    Chattanooga, Tennessee, 37411

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania, 16066

  • Hoopes Vision

    Draper, Utah, 84020

  • Cincinnati Eye Institute

    Edgewood, Kentucky, 41017

  • The Cataract and Glaucoma Center

    El Paso, Texas, 79902

  • Drs. Fine, Hoffman & Sims, LLC

    Eugene, Oregon, 97401

  • Orange County Ophthalmology

    Garden Grove, California, 92843

  • Lugene Eye Institute

    Glendale, California, 91204

  • Cornerstone Eye Care

    High Point, North Carolina, 27262

  • Chicago Cornea Consultants, Ltd.

    Hoffman Estates, Illinois, 60169

  • Houston Eye Associates

    Houston, Texas, 77024

  • Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center

    Houston, Texas, 77034

  • Whitsett Vision Group

    Houston, Texas, 77055

  • The Ocular Surface Institute (TOSI), University of Houston

    Houston, Texas, 77204

  • Price Vision Group

    Indianapolis, Indiana, 46260

  • The Gavin Herbert Eye Institute

    Irvine, California, 92697-4375

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Tauber Eye Center

    Kansas City, Missouri, 64111

  • Eye Care Specialists

    Kingston, Pennsylvania, 18704

  • Brazosport Eye Institute

    Lake Jackson, Texas, 77566

  • Central Florida Eye Associates

    Lakeland, Florida, 33805

  • Shettle Eye Research, Inc

    Largo, Florida, 33773

  • Abrams Eye Institute

    Las Vegas, Nevada, 89148

  • Koffler Vision Group

    Lexington, Kentucky, 40509

  • Macy Eye Center

    Los Angeles, California, 90048

  • Advanced Vision Care

    Los Angeles, California, 90067

  • The Eye Care Institute

    Louisville, Kentucky, 40206

  • Taustine Eye Center

    Louisville, Kentucky, 40217

  • Total Eye Care, PA

    Memphis, Tennessee, 38119

  • North Valley Eye Medical Group

    Mission Hills, California

  • Regional Eye Associates

    Morgantown, West Virginia, 26505

  • Eye Care Centers Management, Inc. (Clayton Eye Center)

    Morrow, Georgia, 30260

  • Toyos Clinic

    Nashville, Tennessee, 37215

  • John-Kenyon American Eye Institute

    New Albany, Indiana, 47150

  • Raymond Fong, MDPC

    New York, New York, 10013

  • Eye Research Foundation

    Newport Beach, California, 92663

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

  • International Eye Associates PA

    Ormond Beach, Florida, 32174

  • Arch Health Partners

    Poway, California, 92064

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670

  • Shasta Eye Medical Group, Inc

    Redding, California, 96002

  • Ophthalmic Consultants of Long Island

    Rockville Centre, New York, 11570

  • Kozlovsky Delay & Winter Eye Consultants, LLC

    San Antonio, Texas, 78230

  • West Coast Eye Care Associates

    San Diego, California, 92115

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Tekwani Vision Center

    St Louis, Missouri, 63128

  • Perez Eye Center/International Research Center

    Tampa, Florida, 33603

  • Wolstan & Goldberg Eye Associates

    Torrance, California, 90505

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

    Washington, Missouri, 63090

  • Comprehensive Eye Care of Central Ohio

    Westerville, Ohio, 43082

  • Michael K Tran, M.D., Inc.

    Westminster, California, 92683

  • Bucci Laser Vision Institute

    Wilkes-Barre, Pennsylvania, 18702

  • James D Branch MD

    Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease

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 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Read the detailed description

This is a Phase 3, 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.

Being tested
KPI-121 0.25% Ophthalmic Suspension, Vehicle of KPI-121 0.25% Ophthalmic Suspension
Keywords
Ocular Discomfort, Pain, Corticosteroid, Hyperemia, Dry Eye
Medical subject headings
Dry Eye Syndromes, Keratoconjunctivitis Sicca, Pain, Hyperemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KPI-121 0.25% Ophthalmic SuspensionDrug

    Also called Loteprednol etabonate

  • Vehicle of KPI-121 0.25% Ophthalmic SuspensionDrug

    Also called Placebo

Study groups in NCT02819284
Study groupRoleWhat they receive
KPI-121 0.25% Ophthalmic SuspensionActive comparatorNot described
Receives: Drug: KPI-121 0.25% Ophthalmic Suspension
Vehicle of KPI-121 0.25% Ophthalmic SuspensionPlacebo comparatorNot described
Receives: Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)

    Comparison of mean change from baseline for 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.

    Measured: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

  2. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)

    Comparison of mean ocular discomfort 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.

    Measured: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Secondary outcomes (12)

  1. Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)

    Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. 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.

    Measured: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

  2. Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)

    Comparison of ocular discomfort scores 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 using 3-day mean scores.

    Measured: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)

  3. Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4

    Comparison of mean ocular discomfort 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.

    Measured: Baseline/Visit 2 (Day 1) - Day 4

  4. Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup

    Comparison of mean ocular discomfort 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, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means.

    Measured: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

  5. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)

    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.

    Measured: Baseline/Visit 2 (Day 1) - Day 3

  6. Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15)

    Comparison of mean eye dryness 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.

    Measured: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

  7. Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8)

    Comparison of mean eye dryness 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.

    Measured: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)

  8. Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)

    Comparison of mean ocular discomfort 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.

    Measured: Baseline/Visit 2 (Day 1) - Day 1

  9. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)

    Comparison of mean ocular discomfort frequency 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.

    Measured: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

  10. Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)

    Comparison of mean ocular discomfort frequency 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.

    Measured: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)

  11. Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)

    Comparison of mean corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe.

    Measured: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

  12. Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)

    Comparison of mean nasal corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe.

    Measured: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
909 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02819284
Sponsor's protocol ID
KPI-121-C-007
Acronym
STRIDE 2
Status last verified
Nov 2020
First submitted
28 Jun 2016
Last updated
5 Jan 2021
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KPI-121 0.25% Ophthalmic Suspension in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Kala Pharmaceuticals, Inc. at 62 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) (time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02819284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.

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