Safety and Efficacy of KPI-121 in Subjects With DED

NCT03616899 | Completed Phase 3 Results FDA Drug

• 1 other identifier: KPI-121-C-011
• Study Type: interventional
• Target: 901
• Locations: 1 country
• Sites: 81

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).

Conditions

Kerato Conjunctivitis Sicca

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• 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)

• Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor

  Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

• 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)

• 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)

• 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)

Study Arms (2)

KPI-121 0.25% Ophthalmic Suspension

ACTIVE COMPARATOR

Drug: KPI-121 Ophthalmic Suspension

Vehicle of KPI-121 0.25% Ophthalmic Suspension

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

KPI-121 Ophthalmic Suspension DRUG

KPI-121 Ophthalmic Suspension

KPI-121 0.25% Ophthalmic Suspension

Vehicle DRUG

Vehicle for KPI-121 0.25% ophthalmic suspension

Vehicle of KPI-121 0.25% Ophthalmic Suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a documented clinical diagnosis of dry eye disease in both eyes

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kala Pharmaceuticals, Inc.: lead

Study Sites (81)

Investigator #133

Birmingham, Alabama, 35294, United States

Location

Investigator #278

Dothan, Alabama, 36301, United States

Location

Investigator #146

Chandler, Arizona, 85224, United States

Location

Investigator #148

Phoenix, Arizona, 85032, United States

Location

Investigator #280

Prescott, Arizona, 86301, United States

Location

Investigator #276

Sun City, Arizona, 85351, United States

Location

Investigator #185

Azusa, California, 91702, United States

Location

Investigator #143

Garden Grove, California, 92843, United States

Location

Investigator #147

Glendale, California, 91204, United States

Location

Investigator #272

Hemet, California, 92545, United States

Location

Investigator #155

Inglewood, California, 90301, United States

Location

Investigator #273

Long Beach, California, 90805, United States

Location

Investigator #130

Mission Hills, California, 91345, United States

Location

Investigator #247

Murrieta, California, 92562, United States

Location

Investigator #215

Newport Beach, California, 92663, United States

Location

Site #111

Rancho Cordova, California, 95670, United States

Location

Investigator #271

Santa Ana, California, 92705, United States

Location

Investigator #107

Torrance, California, 90505, United States

Location

Investigator #213

Westminster, California, 92683, United States

Location

Investigator #218

Littleton, Colorado, 80120, United States

Location

Investigator #184

Brooksville, Florida, 34613, United States

Location

Investigator #262

Delray Beach, Florida, 33484, United States

Location

Investigator #279

Fort Myers, Florida, 33901, United States

Location

Investigator #265

Jacksonville, Florida, 32256, United States

Location

Investigator #157

Largo, Florida, 33773, United States

Location

Investigator #189

Tampa, Florida, 33603, United States

Location

Investigator #136

Morrow, Georgia, 30260, United States

Location

Investigator #268

Roswell, Georgia, 30076, United States

Location

Investigator #266

Chicago, Illinois, 60616, United States

Location

Investigator #187

Hoffman Estates, Illinois, 60169, United States

Location

Investigator #151

Lake Villa, Illinois, 60046, United States

Location

Investigator #128

Indianapolis, Indiana, 46260, United States

Location

Investigator #250

Indianapolis, Indiana, 46290, United States

Location

Investigator #125

New Albany, Indiana, 47150, United States

Location

Investigator #274

Lexington, Kentucky, 40517, United States

Location

Investigator #195

Louisville, Kentucky, 40206, United States

Location

Investigator #168

Louisville, Kentucky, 40220, United States

Location

Investigator #219

Winchester, Massachusetts, 01890, United States

Location

Investigator #267

Kansas City, Missouri, 64133, United States

Location

Investigator #123

St Louis, Missouri, 63128, United States

Location

Investigator #106

St Louis, Missouri, 63131, United States

Location

Investigator #126

St Louis, Missouri, 63131, United States

Location

Investigator #131

Washington, Missouri, 63090, United States

Location

Investigator #281

Henderson, Nevada, 89052, United States

Location

Investigator #275

Las Vegas, Nevada, 89123, United States

Location

Investigator #263

Las Vegas, Nevada, 89145, United States

Location

Investigator #138

Las Vegas, Nevada, 89148, United States

Location

Investigator #105

New York, New York, 10013, United States

Location

Investigator #108

Rochester, New York, 14618, United States

Location

Investigator #132

Wantagh, New York, 11793, United States

Location

Investigator #264

Asheville, North Carolina, 28803, United States

Location

Investigator #217

Durham, North Carolina, 27704, United States

Location

Investigator #149

Durham, North Carolina, 27710, United States

Location

Investigator #102

High Point, North Carolina, 27262, United States

Location

Investigator #163

Raleigh, North Carolina, 27603, United States

Location

Investigator #282

Southern Pines, North Carolina, 28387, United States

Location

Investigator #269

Cincinnati, Ohio, 45242, United States

Location

Investigator #142

Cincinnati, Ohio, 45247, United States

Location

Investigator #137

Cleveland, Ohio, 44115, United States

Location

Investigator #171

Mason, Ohio, 45040, United States

Location

Investigator #224

Cranberry Township, Pennsylvania, 16066, United States

Location

Investigator #156

Kingston, Pennsylvania, 18704, United States

Location

Investigator #200

Lancaster, Pennsylvania, 17601, United States

Location

Investigator #277

West Mifflin, Pennsylvania, 15122, United States

Location

Investigator #240

Rapid City, South Dakota, 57701, United States

Location

Investigator #127

Memphis, Tennessee, 38119, United States

Location

Investigator #270

Austin, Texas, 78681, United States

Location

Investigator #188

Austin, Texas, 78731, United States

Location

Investigator #174

Cedar Park, Texas, 78613, United States

Location

Investigator #140

El Paso, Texas, 79902, United States

Location

Investigator #124

Houston, Texas, 77055, United States

Location

Investigator #259

Houston, Texas, 77204, United States

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Investigator #175

Lakeway, Texas, 78734, United States

Location

Investigator #182

League City, Texas, 77573, United States

Location

Investigator #191

League City, Texas, 77573, United States

Location

Site #177

San Antonio, Texas, 78209, United States

Location

Investigator #258

San Antonio, Texas, 78229, United States

Location

Investigator #186

San Antonio, Texas, 78230, United States

Location

Investigator #176

San Antonio, Texas, 78240, United States

Location

Investigator #222

Layton, Utah, 84041, United States

Location

Investigator #119

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: VP, Clinical Development
• Organization: Kala Pharmaceuticals, Inc

Results011@kalarx.com

(781) 996-5252

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: July 10, 2018
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: April 2, 2021
• Results First Posted: April 2, 2021

Record last verified: 2021-02

Locations

US (81)