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

NCT02163824 | Completed Phase 3 Results

• 1 other identifier: KPI-121-C-001
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 23

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.

Conditions

Ocular Infections, Irritations and Inflammations

Keywords

postsurgical; postoperative; ocular; cataract; inflammation; pain; corticosteroid

Outcome Measures

Primary Outcomes (2)

• Resolution of Anterior Chamber Cells

  Subjects with complete resolution of anterior chamber cells (cell score = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6. 0= No cells seen 1. 1 to 5 cells 2. 6 to 15 cells 3. 16 to 30 cells 4. greater than 30 cells

  Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)

• Resolution of Ocular Pain

  Subjects with complete resolution of pain (grade = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6.

  Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)

Secondary Outcomes (4)

• Anterior Chamber Cell Grade at Visit 5.

  Visit 5 (postoperative day 8)

• Anterior Chamber Cell Grade at Visit 6.

  Visit 6 (postoperative day 15)

• Ocular Pain Grades at Day 8.

  Visit 5 (postoperative day 8)

• Ocular Pain Grades at Day 15.

  Visit 6 (postoperative day 15)

Study Arms (4)

KPI-121 0.25% QID

ACTIVE COMPARATOR

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 0.25%

KPI-121 1.0% BID

ACTIVE COMPARATOR

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 1.0%

Vehicle of KPI-121 0.25%

PLACEBO COMPARATOR

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 0.25%

Vehicle of KPI-121 1.0%

PLACEBO COMPARATOR

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 1.0%

Interventions

KPI-121 0.25% DRUG

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.

Also known as: KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonate 0.25%

KPI-121 0.25% QID

KPI-121 1.0% DRUG

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.

Also known as: KPI-121 1.0% Ophthalmic Suspension, Loteprednol etabonate 1.0%

KPI-121 1.0% BID

Vehicle of KPI-121 0.25% DRUG

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.

Also known as: Vehicle of KPI-121 0.25% Ophthalmic Suspension

Vehicle of KPI-121 0.25%

Vehicle of KPI-121 1.0% DRUG

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.

Also known as: Vehicle of KPI-121 1.0% Ophthalmic Suspension

Vehicle of KPI-121 1.0%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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, 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.

Sponsors & Collaborators

• Kala Pharmaceuticals, Inc.: lead

Study Sites (23)

Sall Research Medical Center

Artesia, California, 90701, United States

Location

North Valley Eye Medical Group

Mission Hills, California, 91345, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Clayton Eye Center

Morrow, Georgia, 30260, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

John-Kenyon American Eye Institute

New Albany, Indiana, 47150, United States

Location

Taustine Eye Center

Louisville, Kentucky, 40217, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63128, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Ophthalmology Consultants

St Louis, Missouri, 63131, United States

Location

Las Vegas Physicians Research Group

Henderson, Nevada, 89052, United States

Location

Raymond Fong, MDPC

New York, New York, 10013, United States

Location

Rochester Ophthalmological Group, PC

Rochester, New York, 14618, United States

Location

Cornerstone Eye Care

High Point, North Carolina, 27262, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

The Eye Center of Columbus

Columbus, Ohio, 43215, United States

Location

Westside Research, LLC

Spartanburg, South Carolina, 29306, United States

Location

The Eye Clinic of Texas, Affiliate of Houston Eye Associates

League City, Texas, 77573, United States

Location

R&R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

Kozlovsky Delay & Winter Eye Consultants, LLC

San Antonio, Texas, 78230, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Eye Infections; Inflammation; Cataract; Pain

Condition Hierarchy (Ancestors)

Infections; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lens Diseases; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: VP, Clinical Development
• Organization: Kala Pharmaceuticals, Inc

Results001@kalarx.com

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 12, 2014
• First Posted: June 16, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 29, 2021
• Results First Posted: December 22, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)