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Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation (Hawaii-1)

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ClinicalTrials.gov Identifier: NCT02163824
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Brief Summary:
The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery. The efficacy and safety of two different concentrations and two different dosing regimens of KPI-121 are also being assessed.

Condition or disease Intervention/treatment Phase
Ocular Infections, Irritations and Inflammations Drug: KPI-121 Drug: Vehicle of KPI-121 Phase 3

Detailed Description:

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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Double-Masked, Randomized, Controlled Trial of KPI-121 in Postsurgical Inflammation
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: KPI-121
KPI-121 drug product will be supplied in two strengths: 0.25% and 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Other Names:
  • KPI-121 0.25% Ophthalmic Suspension
  • Loteprednol etabonate

Active Comparator: 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.
Drug: KPI-121
KPI-121 drug product will be supplied in two strengths: 0.25% and 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Other Names:
  • KPI-121 0.25% Ophthalmic Suspension
  • Loteprednol etabonate

Placebo Comparator: Placebo A QID
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.
Drug: Vehicle of KPI-121
Vehicle of KPI-121 0.25% Ophthalmic Suspension will be dosed QID (Placebo A), Vehicle of KPI-121 1.0 % Ophthalmic Suspension will be dosed BID (Placebo B).
Other Names:
  • Vehicle of KPI-121 0.25% Ophthalmic Suspension
  • Placebo A
  • Vehicle of KPI-121 1.0% Ophthalmic Suspension
  • Placebo B

Placebo Comparator: Placebo B BID
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.
Drug: Vehicle of KPI-121
Vehicle of KPI-121 0.25% Ophthalmic Suspension will be dosed QID (Placebo A), Vehicle of KPI-121 1.0 % Ophthalmic Suspension will be dosed BID (Placebo B).
Other Names:
  • Vehicle of KPI-121 0.25% Ophthalmic Suspension
  • Placebo A
  • Vehicle of KPI-121 1.0% Ophthalmic Suspension
  • Placebo B




Primary Outcome Measures :
  1. Resolution of Anterior Chamber Cells [ Time Frame: Visit 5 (postoperative day 8) ]
    Subjects with complete resolution of anterior chamber cells (cell score = 0) in the study eye at Visit 5

  2. Resolution of Ocular Pain [ Time Frame: Visit 5 (postoperative day 8) ]
    Subjects with resolution of ocular pain (grade = 0) in the study eye at Visit 5

  3. Resolution of Ocular Pain [ Time Frame: Visit 6 (postoperative day 15) ]
    Subjects with resolution of ocular pain (grade = 0) in the study eye at Visit 6

  4. Resolution of Anterior Chamber Cells [ Time Frame: Visit 6 (postoperative day 15) ]
    Subjects with complete resolution of anterior chamber cells (cell score = 0) in the study eye at Visit 6


Secondary Outcome Measures :
  1. Resolution of both Anterior Chamber Cell and Ocular Pain [ Time Frame: Visit 5 (postoperative day 8) ]
    Subjects with complete resolution (grade = 0) of anterior chamber cells complete resolution (grade = 0) of ocular pain at Visit 5

  2. Resolution of both Anterior Chamber Cells and Ocular Pain [ Time Frame: Visit 6 (postoperative day 15) ]
    Subjects with complete resolution (grade = 0) of anterior chamber cells and complete resolution (grade = 0) of ocular pain at Visit 6



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

FURTHER STUDY DETAILS PROVIDED BY KALA PHARMACEUTICALS, INC.

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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163824


Locations
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United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
Martel Eye Medical Group
Rancho Cordova, California, United States, 95670
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505
United States, Georgia
Clayton Eye Center
Morrow, Georgia, United States, 30260
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
John-Kenyon American Eye Institute
New Albany, Indiana, United States, 47150
United States, Kentucky
Taustine Eye Center
Louisville, Kentucky, United States, 40217
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
Tekwani Vision Center
Saint Louis, Missouri, United States, 63128
Ophthalmology Associates
Saint Louis, Missouri, United States, 63131
Ophthalmology Consultants
Saint Louis, Missouri, United States, 63131
United States, Nevada
Las Vegas Physicians Research Group
Henderson, Nevada, United States, 89052
United States, New York
Raymond Fong, MDPC
New York, New York, United States, 10013
Rochester Ophthalmological Group, PC
Rochester, New York, United States, 14618
United States, North Carolina
Cornerstone Eye Care
High Point, North Carolina, United States, 27262
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
The Eye Center of Columbus
Columbus, Ohio, United States, 43215
United States, South Carolina
Westside Research, LLC
Spartanburg, South Carolina, United States, 29306
United States, Texas
The Eye Clinic of Texas, Affiliate of Houston Eye Associates
League City, Texas, United States, 77573
R&R Eye Research, LLC
San Antonio, Texas, United States, 78229
Kozlovsky Delay & Winter Eye Consultants, LLC
San Antonio, Texas, United States, 78230
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Kala Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Ranjan Malhotra, MD Ophthalmology Associates
Principal Investigator: Raymond Fong, MD Raymond Fong, MDPC
Principal Investigator: Joseph Gira, MD Ophthalmology Consultants
Principal Investigator: Damien Goldberg, MD Wolstan & Goldberg Eye Associates
Principal Investigator: Paul Hartman, MD Rochester Ophthalmological Group, PC
Principal Investigator: Joseph Martel, MD Martel Eye Medical Group
Principal Investigator: Bernard Milstein, MD The Eye Clinic of Texas, affiliate Houston Eye Associates
Principal Investigator: Sebastian Mora, DO Kozlovsky Delay & Winter Eye Consultants, LLC
Principal Investigator: Francis Price, MD Price Vision Group
Principal Investigator: Charles Reilly, MD R&R Eye Research, LLC
Principal Investigator: Robert Smyth-Medina, MD North Valley Eye Medical Group
Principal Investigator: Joseph Tauber, MD Tauber Eye Center
Principal Investigator: Lloyd Taustine, MD Taustine Eye Center
Principal Investigator: Nevin Tekwani, MD Tekwani Vision Center
Principal Investigator: Robert DaVanzo, MD Cornerstone Eye Care
Principal Investigator: Kenneth Sall, MD Sall Research Medical Center
Principal Investigator: Steve Wilson, OD John-Kenyon American Eye Institute
Principal Investigator: Derick DelMonte, MD Duke University
Principal Investigator: Alice Epitropoulos, MD The Eye Center of Columbus
Principal Investigator: Douglas Lorenz, DO Westfield Nevada Eye and Ear
Principal Investigator: Michael Nordlund, MD, PhD Cincinnati Eye Institute
Principal Investigator: Lawrence Roel, MD, PhD Westside Research, LLC
Principal Investigator: John Sheppard, MD Virginia Eye Consultants
Principal Investigator: Harvey B Dubiner, MD Clayton Eye Center

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Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02163824     History of Changes
Other Study ID Numbers: KPI-121-C-001
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kala Pharmaceuticals, Inc.:
postsurgical
postoperative
ocular
cataract
inflammation
pain
corticosteroid

Additional relevant MeSH terms:
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Inflammation
Eye Infections
Pathologic Processes
Infection
Eye Diseases
Loteprednol Etabonate
Anti-Allergic Agents