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

• 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: Kala Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Kala Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: June 28, 2016
• First Posted Date: June 30, 2016
• Results First Submitted Date: September 21, 2020
• Results First Posted Date: December 3, 2020
• Last Update Posted Date: January 5, 2021
• Actual Study Start Date: June 2016
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 19, 2018): 909
• Original Estimated Enrollment (submitted: June 28, 2016): 900
• Actual Study Completion Date: September 2017
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02819284
• Other Study ID Numbers: KPI-121-C-007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Kala Pharmaceuticals, Inc.
• Study Sponsor: Kala Pharmaceuticals, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Kala Pharmaceuticals, Inc.
• Verification Date: November 2020