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

Phase 3

Completed

Conditions: Keratoconjunctivitis Sicca
Dry Eye Syndromes

Interventions: Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Drug: KPI-121 0.25% Ophthalmic Suspension

Registration Number: NCT02819284

Lead Sponsor: 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 909

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle of KPI-121 0.25% Ophthalmic Suspension	Vehicle of KPI-121 0.25% Ophthalmic Suspension	-
KPI-121 0.25% Ophthalmic Suspension	KPI-121 0.25% Ophthalmic Suspension	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)	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)	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

Name	Time	Method
Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)	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)	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	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/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)	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)	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)	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)	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)	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)	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)	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)	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.
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup	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.

Trial Locations

Locations (62): UAB School of Optometry
🇺🇸
Birmingham, Alabama, United States
Arizona Eye Center
🇺🇸
Chandler, Arizona, United States
NEA Baptist Clinic
🇺🇸
Jonesboro, Arkansas, United States
Sall Research Medical Center
🇺🇸
Artesia, California, United States
Milton M. Hom, OD, FAAO
🇺🇸
Azusa, California, United States
Family Eye Care Center
🇺🇸
Campbell, California, United States
Orange County Ophthalmology
🇺🇸
Garden Grove, California, United States
Lugene Eye Institute
🇺🇸
Glendale, California, United States
The Gavin Herbert Eye Institute
🇺🇸
Irvine, California, United States
Macy Eye Center
🇺🇸
Los Angeles, California, United States
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UAB School of Optometry
🇺🇸Birmingham, Alabama, United States