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

Phase 3

Completed

• Conditions: Keratoconjunctivitis Sicca; Dry Eye Syndromes
• Interventions: Drug: KPI-121 0.25% Ophthalmic Suspension; Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension

• Registration Number: NCT02813265
• 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-24
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Disposition First Submitted: 2018-07-12
• Disposition First Submitted QC: 2018-07-12
• Disposition First Posted: 2018-07-17
• Results First Submitted: 2020-09-21
• Results First Submitted QC: 2020-11-09
• Results First Posted: 2020-12-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 918

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, Intraocular Pressure (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
KPI-121 0.25% Ophthalmic Suspension	KPI-121 0.25% Ophthalmic Suspension	-
Vehicle of KPI-121 0.25% Ophthalmic Suspension	Vehicle of 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) and to Visit 4 (Day 15)	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. 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 Corneal Fluorescein Staining Score at Visit 4 (Day 15)	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)	Comparison of mean corneal fluorescein staining 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 Ocular Discomfort Severity at Visit 4 (Day 15)	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)	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) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)	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, in a sub-group of participants with more severe ocular discomfort at baseline.

Secondary Outcome Measures

Name	Time	Method
Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort	Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)	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, in a sub-group of participants with more severe ocular discomfort at baseline.
Change From Baseline/Visit 2 (Day 1) in Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)	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 in a sub-group of participants with more severe ocular discomfort at baseline.. 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.
Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)	Visit 4 (Day 15)	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. 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) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)	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. 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 in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort.	Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)	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 in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)	Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)	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.
Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)	Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores. 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 in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)	Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)	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 in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)	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. 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.

Trial Locations

Locations (60)

Cornea and Cataract Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Schwartz Laser Eye Center; 🇺🇸 Scottsdale, Arizona, United States

Eyecare Arkansas, P.A.; 🇺🇸 Little Rock, Arkansas, United States

Little Rock Eye Clinic, LLP; 🇺🇸 Little Rock, Arkansas, United States

Sall Research Medical Center; 🇺🇸 Artesia, California, United States

Orange County Ophthalmology Medical Group; 🇺🇸 Garden Grove, California, United States

United Medical Research Institute; 🇺🇸 Inglewood, California, United States

North Valley Eye Medical Group; 🇺🇸 Mission Hills, California, United States

Montebello Medical Center, Inc.; 🇺🇸 Montebello, California, United States

LoBue Laser and Eye Medical Center; 🇺🇸 Murrieta, California, United States

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