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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
Results First Posted : December 3, 2020
Last Update Posted : January 5, 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
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.
Study Design
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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

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: KPI-121 0.25% Ophthalmic Suspension Drug: KPI-121 0.25% Ophthalmic Suspension
Other Name: Loteprednol etabonate
Placebo Comparator: Vehicle of KPI-121 0.25% Ophthalmic Suspension Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Other Name: Placebo


Outcome Measures
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Primary 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) - 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.

  2. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) [ Time Frame: Baseline/Visit 2 (Day 1) - 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.


Secondary Outcome Measures :
  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) [ Time Frame: Baseline/Visit 2 (Day 1) - 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.

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

  3. Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4 [ Time Frame: Baseline/Visit 2 (Day 1) - 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.

  4. Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup [ Time Frame: Baseline/Visit 2 (Day 1) - 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, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means.

  5. Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary) [ Time Frame: Baseline/Visit 2 (Day 1) - Day 3 ]
    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.

  6. Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15) [ Time Frame: Baseline/Visit 2 (Day 1) - 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.

  7. Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8) [ Time Frame: Baseline/Visit 2 (Day 1) - 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.

  8. Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1) [ Time Frame: Baseline/Visit 2 (Day 1) - 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.

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

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

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

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


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): NCT02819284


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] July 6, 2017

More Information
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Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02819284    
Other Study ID Numbers: KPI-121-C-007
First Posted: June 30, 2016    Key Record Dates
Results First Posted: December 3, 2020
Last Update Posted: January 5, 2021
Last Verified: November 2020
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
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Loteprednol Etabonate
Anti-Allergic Agents