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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.

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE June 30, 2016
Results First Submitted Date  ICMJE September 21, 2020
Results First Posted Date  ICMJE December 3, 2020
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • 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.
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease
Official Title  ICMJE A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eye Syndromes
  • Keratoconjunctivitis Sicca
Intervention  ICMJE
  • Drug: KPI-121 0.25% Ophthalmic Suspension
    Other Name: Loteprednol etabonate
  • Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: KPI-121 0.25% Ophthalmic Suspension
    Intervention: Drug: KPI-121 0.25% Ophthalmic Suspension
  • Placebo Comparator: Vehicle of KPI-121 0.25% Ophthalmic Suspension
    Intervention: Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2018)
909
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2016)
900
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02819284
Other Study ID Numbers  ICMJE KPI-121-C-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kala Pharmaceuticals, Inc.
Study Sponsor  ICMJE Kala Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kala Pharmaceuticals, Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP