Safety and Efficacy of KPI-121 in Subjects With DED

Phase 3

Completed

• Conditions: Kerato Conjunctivitis Sicca
• Interventions: Drug: KPI-121 Ophthalmic Suspension; Drug: Vehicle

• Registration Number: NCT03616899
• 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: 2018-07-10
• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-06
• Primary Completion: 2020-02-05
• Study Completion: 2020-02-05
• Status Verified: 2021-02
• Results First Submitted: 2021-02-09
• Results First Submitted QC: 2021-03-09
• Last Update Submitted: 2021-03-09
• Results First Posted: 2021-04-02
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 901

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
KPI-121 0.25% Ophthalmic Suspension	KPI-121 Ophthalmic Suspension	-
Vehicle of KPI-121 0.25% Ophthalmic Suspension	Vehicle	-

Primary Outcome Measures

Name	Time	Method
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 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 Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean	Baseline/Visit 2 (Day 1) 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 in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor	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 Ocular Discomfort Severity at Visit 3 (Day 8)	Baseline/Visit 2 (Day 1) 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 From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)	Baseline/Visit 2 (Day 1) 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.

Trial Locations

Locations (81)

Investigator #133; 🇺🇸 Birmingham, Alabama, United States

Investigator #278; 🇺🇸 Dothan, Alabama, United States

Investigator #146; 🇺🇸 Chandler, Arizona, United States

Investigator #148; 🇺🇸 Phoenix, Arizona, United States

Investigator #280; 🇺🇸 Prescott, Arizona, United States

Investigator #276; 🇺🇸 Sun City, Arizona, United States

Investigator #185; 🇺🇸 Azusa, California, United States

Investigator #143; 🇺🇸 Garden Grove, California, United States

Investigator #147; 🇺🇸 Glendale, California, United States

Investigator #272; 🇺🇸 Hemet, California, United States

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