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Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease (STRIDE 2)

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ClinicalTrials.gov Identifier: NCT02819284
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : July 17, 2018
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 14 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 0.25% Ophthalmic Suspension Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 909 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Active Comparator: Active Comparator: KPI-121 0.25% Ophthalmic Suspension Drug: KPI-121 0.25% Ophthalmic Suspension
Other Name: Loteprednol etabonate

Placebo Comparator: Placebo Comparator: Vehicle of KPI-121 0.25% Ophthalmic Suspe Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Other Name: Placebo




Primary Outcome Measures :
  1. Bulbar Conjunctival Hyperemia [ Time Frame: Week 2 ]
    Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale.

  2. Ocular Discomfort [ Time Frame: Week 2 ]
    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



Information from the National Library of Medicine

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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 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.

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): NCT02819284


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Sponsors and Collaborators
Kala Pharmaceuticals, Inc.

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Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02819284     History of Changes
Other Study ID Numbers: KPI-121-C-007
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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