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

Phase 3CompletedNCT02819284

Kala Pharmaceuticals, Inc.909 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

909

Conditions

Dry Eye Syndromes Keratoconjunctivitis Sicca

Interventions

KPI-121 0.25% Ophthalmic SuspensionDRUG

Vehicle of KPI-121 0.25% Ophthalmic SuspensionDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (62)

Outcomes

Primary Outcomes

Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at 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.

Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at 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.

Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Secondary Outcomes

Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at 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.

Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at 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.

Time frame: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)

Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to 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.

Data from ClinicalTrials.gov

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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

...and 52 more locations

Time frame: Baseline/Visit 2 (Day 1) - Day 4

Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup

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.

Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)

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.

Time frame: Baseline/Visit 2 (Day 1) - Day 3

Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at 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.

Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at 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.

Time frame: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)

Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (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.

Time frame: Baseline/Visit 2 (Day 1) - Day 1

Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at 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.

Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

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)

Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at 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.

Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at 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.

Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)