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Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain

Primary Purpose

Post Surgical Ocular Inflammation and Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
KPI-121 1% Ophthalmic Suspension dosed BID
Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Sponsored by
Kala Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Surgical Ocular Inflammation and Pain focused on measuring postsurgical, postoperative, ocular, cataract, inflammation, pain, corticosteroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Arizona Eye Center
  • Cornea and Cataract Consultants of CA
  • Sall Research Medical Center
  • Orange County Ophthalmology
  • Lugene Eye Institute
  • Inland Eye Specialists
  • United Medical Research Institute
  • LoBue Laser and Eye Medical Center
  • Pendleton Eye Center
  • North Bay Eye Associates, Inc.
  • Arch Health Partners
  • Martel Eye Medical Group
  • Shasta Eye Medical Group, Inc
  • Eye Center of Northern Colorado, PC
  • Eye Associates of Fort Myers
  • Levenson Eye Associates
  • Shettle Eye Research, Inc
  • International Research Center
  • Chicago Cornea Consultants, Ltd.
  • Jacksoneye, S. C.
  • The Eye Care Institute
  • Great Lakes Eye Care
  • Minnesota Eye Consultants, PA
  • Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
  • Abrams Eye Institute
  • Duke University Eye Center
  • Apex Eye
  • Roseburg Research Associates, LLC
  • Eye Care Specialists
  • Carolina Cataract & Laser Center
  • Carolina Eyecare Physicians, LLC
  • Texan Eye, PA / Keystone Research, Ltd
  • The Cataract & Glaucoma Center
  • Houston Eye Associates
  • Kozlovsky Delay & Winter Eye Consultants, LLC Corona Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

KPI-121 1.0% Ophthalmic Suspension

Vehicle of KPI-121 Ophthalmic Suspension

Arm Description

dosed BID

dosed BID

Outcomes

Primary Outcome Measures

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 - 5 cells = 6 - 15 cells = 16 - 30 cells = greater than 30 cells
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 = Minimal = Mild = Moderate = Moderately Severe = Severe

Secondary Outcome Measures

Complete Resolution of Ocular Pain at Day 4
Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 4 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 = Minimal = Mild = Moderate = Moderately Severe = Severe
Complete Resolution of Anterior Chamber (AC) Flare at Day 4
Number and percentage of subjects with complete resolution of AC flare in the surgical eye (study eye) at Day 4 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 flare based on the following scale wherein higher scores indicate a higher degree of flare present and a decrease across time indicates the condition is getting better. Anterior Chamber Flare 0 = None = Mild (trace to clearly noticeable, visible) = Moderate (without plastic aqueous humor) = Marked (with plastic aqueous humor) = Severe (with fibrin deposits and/or clots)
Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4
The difference in mean changes from BL in AC cell count grade at Day 4 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 - 5 cells = 6 - 15 cells = 16 - 30 cells = greater than 30 cells

Full Information

First Posted
June 3, 2016
Last Updated
November 24, 2020
Sponsor
Kala Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02793817
Brief Title
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kala Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Surgical Ocular Inflammation and Pain
Keywords
postsurgical, postoperative, ocular, cataract, inflammation, pain, corticosteroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KPI-121 1.0% Ophthalmic Suspension
Arm Type
Active Comparator
Arm Description
dosed BID
Arm Title
Vehicle of KPI-121 Ophthalmic Suspension
Arm Type
Placebo Comparator
Arm Description
dosed BID
Intervention Type
Drug
Intervention Name(s)
KPI-121 1% Ophthalmic Suspension dosed BID
Other Intervention Name(s)
Loteprednol etabonate
Intervention Type
Drug
Intervention Name(s)
Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Complete Resolution of Anterior Chamber (AC) Cells at Day 8
Description
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 - 5 cells = 6 - 15 cells = 16 - 30 cells = greater than 30 cells
Time Frame
Visit 5 (Day 8) maintained through Visit 6 (Day 15)
Title
Complete Resolution of Ocular Pain at Day 8
Description
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 = Minimal = Mild = Moderate = Moderately Severe = Severe
Time Frame
Visit 5 (Day 8) maintained through Visit 6 (Day 15)
Secondary Outcome Measure Information:
Title
Complete Resolution of Ocular Pain at Day 4
Description
Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 4 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 = Minimal = Mild = Moderate = Moderately Severe = Severe
Time Frame
Visit 4 (Day 4) maintained through Visit 6 (Day 15)
Title
Complete Resolution of Anterior Chamber (AC) Flare at Day 4
Description
Number and percentage of subjects with complete resolution of AC flare in the surgical eye (study eye) at Day 4 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 flare based on the following scale wherein higher scores indicate a higher degree of flare present and a decrease across time indicates the condition is getting better. Anterior Chamber Flare 0 = None = Mild (trace to clearly noticeable, visible) = Moderate (without plastic aqueous humor) = Marked (with plastic aqueous humor) = Severe (with fibrin deposits and/or clots)
Time Frame
Visit 4 (Day 4) maintained through Visit 6 (Day 15)
Title
Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4
Description
The difference in mean changes from BL in AC cell count grade at Day 4 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 - 5 cells = 6 - 15 cells = 16 - 30 cells = greater than 30 cells
Time Frame
Visit 1 (Baseline) and Visit 4 (Day 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Cornea and Cataract Consultants of CA
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Orange County Ophthalmology
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Inland Eye Specialists
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
United Medical Research Institute
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
LoBue Laser and Eye Medical Center
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Pendleton Eye Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
North Bay Eye Associates, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Arch Health Partners
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Shasta Eye Medical Group, Inc
City
Redding
State/Province
California
ZIP/Postal Code
96002
Country
United States
Facility Name
Eye Center of Northern Colorado, PC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
Eye Associates of Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Shettle Eye Research, Inc
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
International Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Chicago Cornea Consultants, Ltd.
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Jacksoneye, S. C.
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Great Lakes Eye Care
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Minnesota Eye Consultants, PA
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Abrams Eye Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Duke University Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
Apex Eye
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States
Facility Name
Roseburg Research Associates, LLC
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97471
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Carolina Cataract & Laser Center
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Carolina Eyecare Physicians, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Texan Eye, PA / Keystone Research, Ltd
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
The Cataract & Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Kozlovsky Delay & Winter Eye Consultants, LLC Corona Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain

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