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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03616899
Other study ID # KPI-121-C-011
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 10, 2018
Est. completion date February 5, 2020

Study information

Verified date February 2021
Source Kala Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Completed
Enrollment 901
Est. completion date February 5, 2020
Est. primary completion date February 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Drug:
KPI-121 Ophthalmic Suspension
KPI-121 Ophthalmic Suspension
Vehicle
Vehicle for KPI-121 0.25% ophthalmic suspension

Locations

Country Name City State
United States Investigator #264 Asheville North Carolina
United States Investigator #188 Austin Texas
United States Investigator #270 Austin Texas
United States Investigator #185 Azusa California
United States Investigator #133 Birmingham Alabama
United States Investigator #184 Brooksville Florida
United States Investigator #174 Cedar Park Texas
United States Investigator #146 Chandler Arizona
United States Investigator #266 Chicago Illinois
United States Investigator #142 Cincinnati Ohio
United States Investigator #269 Cincinnati Ohio
United States Investigator #137 Cleveland Ohio
United States Investigator #224 Cranberry Township Pennsylvania
United States Investigator #262 Delray Beach Florida
United States Investigator #278 Dothan Alabama
United States Investigator #149 Durham North Carolina
United States Investigator #217 Durham North Carolina
United States Investigator #140 El Paso Texas
United States Investigator #279 Fort Myers Florida
United States Investigator #143 Garden Grove California
United States Investigator #147 Glendale California
United States Investigator #272 Hemet California
United States Investigator #281 Henderson Nevada
United States Investigator #102 High Point North Carolina
United States Investigator #187 Hoffman Estates Illinois
United States Investigator #124 Houston Texas
United States Investigator #259 Houston Texas
United States Investigator #128 Indianapolis Indiana
United States Investigator #250 Indianapolis Indiana
United States Investigator #155 Inglewood California
United States Investigator #265 Jacksonville Florida
United States Investigator #267 Kansas City Missouri
United States Investigator #156 Kingston Pennsylvania
United States Investigator #151 Lake Villa Illinois
United States Investigator #175 Lakeway Texas
United States Investigator #200 Lancaster Pennsylvania
United States Investigator #157 Largo Florida
United States Investigator #138 Las Vegas Nevada
United States Investigator #263 Las Vegas Nevada
United States Investigator #275 Las Vegas Nevada
United States Investigator #222 Layton Utah
United States Investigator #182 League City Texas
United States Investigator #191 League City Texas
United States Investigator #274 Lexington Kentucky
United States Investigator #218 Littleton Colorado
United States Investigator #273 Long Beach California
United States Investigator #168 Louisville Kentucky
United States Investigator #195 Louisville Kentucky
United States Investigator #171 Mason Ohio
United States Investigator #127 Memphis Tennessee
United States Investigator #130 Mission Hills California
United States Investigator #136 Morrow Georgia
United States Investigator #247 Murrieta California
United States Investigator #125 New Albany Indiana
United States Investigator #105 New York New York
United States Investigator #215 Newport Beach California
United States Investigator #119 Norfolk Virginia
United States Investigator #148 Phoenix Arizona
United States Investigator #280 Prescott Arizona
United States Investigator #163 Raleigh North Carolina
United States Site #111 Rancho Cordova California
United States Investigator #240 Rapid City South Dakota
United States Investigator #108 Rochester New York
United States Investigator #268 Roswell Georgia
United States Investigator #106 Saint Louis Missouri
United States Investigator #123 Saint Louis Missouri
United States Investigator #126 Saint Louis Missouri
United States Investigator #176 San Antonio Texas
United States Investigator #186 San Antonio Texas
United States Investigator #258 San Antonio Texas
United States Site #177 San Antonio Texas
United States Investigator #271 Santa Ana California
United States Investigator #282 Southern Pines North Carolina
United States Investigator #276 Sun City Arizona
United States Investigator #189 Tampa Florida
United States Investigator #107 Torrance California
United States Investigator #132 Wantagh New York
United States Investigator #131 Washington Missouri
United States Investigator #277 West Mifflin Pennsylvania
United States Investigator #213 Westminster California
United States Investigator #219 Winchester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Kala Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at 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. Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Primary 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 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. Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at 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. Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor 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. Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at 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. Baseline/Visit 2 (Day 1) to Visit 3 (Day 8)
Secondary Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at 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. Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)
Secondary Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean 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. Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)
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