Clinical trial NCT02163824: Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation
Official title: A Phase III, Double-Masked, Randomized, Controlled Trial of KPI-121 in Postsurgical Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Infections, Irritations and Inflammations
Keywords: postsurgical
postoperative
ocular
cataract
inflammation
pain
corticosteroid
Lead sponsor: Kala Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Resolution of Anterior Chamber Cells
timeFrame: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)
measure: Resolution of Ocular Pain
timeFrame: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)
Secondary outcomes:
measure: Anterior Chamber Cell Grade at Visit 5.
timeFrame: Visit 5 (postoperative day 8)
measure: Anterior Chamber Cell Grade at Visit 6.
timeFrame: Visit 6 (postoperative day 15)
measure: Ocular Pain Grades at Day 8.
timeFrame: Visit 5 (postoperative day 8)
measure: Ocular Pain Grades at Day 15.
timeFrame: Visit 6 (postoperative day 15)
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: New Albany
country: United States
facility: John-Kenyon American Eye Institute
state: Indiana
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Consultants
state: Missouri
city: Henderson
country: United States
facility: Las Vegas Physicians Research Group
state: Nevada
city: New York
country: United States
facility: Raymond Fong, MDPC
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Columbus
country: United States
facility: The Eye Center of Columbus
state: Ohio
city: Spartanburg
country: United States
facility: Westside Research, LLC
state: South Carolina
city: League City
country: United States
facility: The Eye Clinic of Texas, Affiliate of Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: R&R Eye Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Kozlovsky Delay & Winter Eye Consultants, LLC
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
References: