Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain
1 other identifier
interventional
520
1 country
35
Brief Summary
The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2016
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 3, 2016
CompletedFirst Posted
Study publicly available on registry
June 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedResults Posted
Study results publicly available
April 17, 2019
CompletedDecember 16, 2020
October 1, 2018
9 months
June 3, 2016
October 25, 2018
November 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complete Resolution of Anterior Chamber (AC) Cells at Day 8
Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells
Visit 5 (Day 8) maintained through Visit 6 (Day 15)
Complete Resolution of Ocular Pain at Day 8
Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes. The following scoring scale was used for ocular pain: 0 = None 1. = Minimal 2. = Mild 3. = Moderate 4. = Moderately Severe 5. = Severe
Visit 5 (Day 8) maintained through Visit 6 (Day 15)
Secondary Outcomes (3)
Complete Resolution of Ocular Pain at Day 4
Visit 4 (Day 4) maintained through Visit 6 (Day 15)
Complete Resolution of Anterior Chamber (AC) Flare at Day 4
Visit 4 (Day 4) maintained through Visit 6 (Day 15)
Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4
Visit 1 (Baseline) and Visit 4 (Day 4)
Study Arms (2)
KPI-121 1.0% Ophthalmic Suspension
ACTIVE COMPARATORdosed BID
Vehicle of KPI-121 Ophthalmic Suspension
PLACEBO COMPARATORdosed BID
Interventions
Eligibility Criteria
You may qualify if:
- Candidates for routine, uncomplicated cataract surgery
- In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.
You may not qualify if:
- Known hypersensitivity/contraindication to study 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; 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 18 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Arizona Eye Center
Chandler, Arizona, 85225, United States
Cornea and Cataract Consultants of CA
Phoenix, Arizona, 85032, United States
Sall Research Medical Center
Artesia, California, 90701, United States
Orange County Ophthalmology
Garden Grove, California, 92843, United States
Lugene Eye Institute
Glendale, California, 91204, United States
Inland Eye Specialists
Hemet, California, 92545, United States
United Medical Research Institute
Inglewood, California, 90301, United States
LoBue Laser and Eye Medical Center
Murrieta, California, 92562, United States
Pendleton Eye Center
Oceanside, California, 92056, United States
North Bay Eye Associates, Inc.
Petaluma, California, 94954, United States
Arch Health Partners
Poway, California, 92064, United States
Martel Eye Medical Group
Rancho Cordova, California, 95670, United States
Shasta Eye Medical Group, Inc
Redding, California, 96002, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80525, United States
Eye Associates of Fort Myers
Fort Myers, Florida, 33901, United States
Levenson Eye Associates
Jacksonville, Florida, 32204, United States
Shettle Eye Research, Inc
Largo, Florida, 33773, United States
International Research Center
Tampa, Florida, 33603, United States
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, 60169, United States
Jacksoneye, S. C.
Lake Villa, Illinois, 60046, United States
The Eye Care Institute
Louisville, Kentucky, 40206, United States
Great Lakes Eye Care
Saint Joseph, Michigan, 49085, United States
Minnesota Eye Consultants, PA
Bloomington, Minnesota, 55431, United States
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
Washington, Missouri, 63090, United States
Abrams Eye Institute
Las Vegas, Nevada, 89148, United States
Duke University Eye Center
Durham, North Carolina, 27703, United States
Apex Eye
Cincinnati, Ohio, 45247, United States
Roseburg Research Associates, LLC
Roseburg, Oregon, 97471, United States
Eye Care Specialists
Kingston, Pennsylvania, 18704, United States
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456, United States
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464, United States
Texan Eye, PA / Keystone Research, Ltd
Austin, Texas, 78731, United States
The Cataract & Glaucoma Center
El Paso, Texas, 79902, United States
Houston Eye Associates
Houston, Texas, 77024, United States
Kozlovsky Delay & Winter Eye Consultants, LLC Corona Research
San Antonio, Texas, 78213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head, Clinical Operations
- Organization
- Kala Pharmaceuticals, Inc.
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
June 3, 2016
First Posted
June 8, 2016
Study Start
June 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
December 16, 2020
Results First Posted
April 17, 2019
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share