Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation
NCT ID: NCT02163824
Last Updated: 2021-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
380 participants
INTERVENTIONAL
2014-05-31
2014-12-31
Brief Summary
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Detailed Description
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Approximately 500 subjects will be screened and up to 402 subjects with one study eye each will be randomized in this study at approximately 25 centers located in the United States. Subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all other eligibility criteria will be randomized to one of four study groups (0.25% four times daily or 1.0% two times daily) or Placebo A four times daily or Placebo B two times daily. Drug product or placebo will be initiated on the day following surgery and instilled as one to two drops in the study eye according to the assigned dosing regimen for 14 days.
This study will include up to 7 clinic visits (including the surgery day) over 18 to 33 days total study duration. Visit 1 (Screening) will occur between 14 to 1 day(s) prior to surgery, and subjects who meet preoperative screening inclusion/exclusion criteria will be entered into the study. At Visit 2 (Surgery/Day 0) subjects will undergo routine cataract surgery according to the Investigator's normal procedures. Visit 3 (Randomization/Day 1) will occur on the day following surgery.
Following randomization, subjects will be instructed to return to the clinic to be evaluated at Visit 4 (Day 3 +2 day), Visit 5 (Day 8 ±1 day), and Visit 6 (Day 15 ±1 day). The last dose of study product will be administered upon completion of 14 days of evaluation. Following the End of Study Product Use Visit (Visit 6; Day 15 ±1 day), subjects will be asked to return to the clinic on Day 17-19 for Visit 7 (Follow-Up) and will be released from the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KPI-121 0.25% QID
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%
KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
KPI-121 1.0% BID
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%
KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
Vehicle of KPI-121 0.25%
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121 0.25%
Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Vehicle of KPI-121 1.0%
Vehicle of KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121 1.0%
Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Interventions
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KPI-121 0.25%
KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
KPI-121 1.0%
KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
Vehicle of KPI-121 0.25%
Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Vehicle of KPI-121 1.0%
Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.
Exclusion Criteria
* 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; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 19 days following surgery.
* In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
18 Years
ALL
No
Sponsors
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Kala Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Sall Research Medical Center
Artesia, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Wolstan & Goldberg Eye Associates
Torrance, California, United States
Clayton Eye Center
Morrow, Georgia, United States
Price Vision Group
Indianapolis, Indiana, United States
John-Kenyon American Eye Institute
New Albany, Indiana, United States
Taustine Eye Center
Louisville, Kentucky, United States
Tauber Eye Center
Kansas City, Missouri, United States
Tekwani Vision Center
St Louis, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
Ophthalmology Consultants
St Louis, Missouri, United States
Las Vegas Physicians Research Group
Henderson, Nevada, United States
Raymond Fong, MDPC
New York, New York, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
Cornerstone Eye Care
High Point, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
The Eye Center of Columbus
Columbus, Ohio, United States
Westside Research, LLC
Spartanburg, South Carolina, United States
The Eye Clinic of Texas, Affiliate of Houston Eye Associates
League City, Texas, United States
R&R Eye Research, LLC
San Antonio, Texas, United States
Kozlovsky Delay & Winter Eye Consultants, LLC
San Antonio, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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KPI-121-C-001
Identifier Type: -
Identifier Source: org_study_id
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