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Safety and Efficacy of KPI-121 in Subjects With DED (STRIDE 3)

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: NCT03616899
Recruitment Status : Completed
First Posted : August 6, 2018
Results First Posted : April 2, 2021
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Study Description
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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
Kerato Conjunctivitis Sicca Drug: KPI-121 Ophthalmic Suspension Drug: Vehicle 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 901 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 (STRIDE 3)
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : February 5, 2020
Actual Study Completion Date : February 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: KPI-121 0.25% Ophthalmic Suspension Drug: KPI-121 Ophthalmic Suspension
KPI-121 Ophthalmic Suspension
Placebo Comparator: Vehicle of KPI-121 0.25% Ophthalmic Suspension Drug: Vehicle
Vehicle for KPI-121 0.25% ophthalmic suspension


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) [ Time Frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15) ]
    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.

  2. Change From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort [ Time Frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15) ]
    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, in a sub-group of participants with more severe ocular discomfort at baseline.


Secondary Outcome Measures :
  1. Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) [ Time Frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15) ]
    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. 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.

  2. Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor [ Time Frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15) ]
    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. 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.

  3. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8) [ Time Frame: Baseline/Visit 2 (Day 1) to Visit 3 (Day 8) ]
    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.

  4. Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15) [ Time Frame: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15) ]
    Comparison of mean corneal fluorescein staining 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.

  5. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean [ Time Frame: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15) ]
    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.


Eligibility Criteria
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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.
Contacts and Locations
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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): NCT03616899


Locations
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Sponsors and Collaborators
Kala Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Kala Pharmaceuticals, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] March 27, 2019

More Information
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Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03616899    
Other Study ID Numbers: KPI-121-C-011
First Posted: August 6, 2018    Key Record Dates
Results First Posted: April 2, 2021
Last Update Posted: April 2, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Conjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases