Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Launched by KALA PHARMACEUTICALS, INC. · Jun 22, 2016
Trial Information
Current as of May 02, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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.
About Kala Pharmaceuticals, Inc.
Kala Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of serious ocular conditions. Leveraging its proprietary drug delivery platform, Kala aims to enhance the efficacy and safety of existing medications while addressing unmet medical needs in the ophthalmic space. With a commitment to advancing patient care, the company is dedicated to conducting rigorous clinical trials to validate the effectiveness of its product candidates and bring transformative solutions to the market.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Memphis, Tennessee, United States
Boynton Beach, Florida, United States
Norfolk, Virginia, United States
Rapid City, South Dakota, United States
Houston, Texas, United States
Inglewood, California, United States
Artesia, California, United States
Pittsburgh, Pennsylvania, United States
Layton, Utah, United States
Slingerlands, New York, United States
Newport Beach, California, United States
Petaluma, California, United States
Fort Myers, Florida, United States
Rochester, New York, United States
Mission Hills, California, United States
San Antonio, Texas, United States
Bloomington, Minnesota, United States
Charlotte, North Carolina, United States
Scottsdale, Arizona, United States
Saint Louis, Missouri, United States
Rancho Cordova, California, United States
Panama City, Florida, United States
Roseburg, Oregon, United States
Las Vegas, Nevada, United States
Saint Louis, Missouri, United States
Overland Park, Kansas, United States
Mclean, Virginia, United States
Cranberry Township, Pennsylvania, United States
San Antonio, Texas, United States
Oceanside, California, United States
Winchester, Massachusetts, United States
League City, Texas, United States
Wantagh, New York, United States
Fargo, North Dakota, United States
Montebello, California, United States
Largo, Florida, United States
Pennington, New Jersey, United States
Indianapolis, Indiana, United States
Lancaster, Pennsylvania, United States
Murrieta, California, United States
Fort Collins, Colorado, United States
Lake Villa, Illinois, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Garden Grove, California, United States
Sacramento, California, United States
Littleton, Colorado, United States
Hamden, Connecticut, United States
Palm Coast, Florida, United States
Albany, Georgia, United States
Chesterfield, Missouri, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Columbus, Ohio, United States
Mason, Ohio, United States
Cedar Park, Texas, United States
Leander, Texas, United States
San Antonio, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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