Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
- Conditions
- Post Surgical Ocular Inflammation and Pain
- Interventions
- Drug: KPI-121 1% Ophthalmic Suspension dosed BIDDrug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID
- Registration Number
- NCT02793817
- Lead Sponsor
- Kala Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 520
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KPI-121 1.0% Ophthalmic Suspension KPI-121 1% Ophthalmic Suspension dosed BID dosed BID Vehicle of KPI-121 Ophthalmic Suspension Vehicle of KPI-121 Ophthalmic Suspension dosed BID dosed BID
- Primary Outcome Measures
Name Time Method Complete Resolution of Anterior Chamber (AC) Cells at Day 8 Visit 5 (Day 8) maintained through Visit 6 (Day 15) 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 cellsComplete Resolution of Ocular Pain at Day 8 Visit 5 (Day 8) maintained through Visit 6 (Day 15) 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
- Secondary Outcome Measures
Name Time Method Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4 Visit 1 (Baseline) and Visit 4 (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. = 1 - 5 cells
2. = 6 - 15 cells
3. = 16 - 30 cells
4. = greater than 30 cellsComplete Resolution of Anterior Chamber (AC) Flare at Day 4 Visit 4 (Day 4) maintained through Visit 6 (Day 15) 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
1. = Mild (trace to clearly noticeable, visible)
2. = Moderate (without plastic aqueous humor)
3. = Marked (with plastic aqueous humor)
4. = Severe (with fibrin deposits and/or clots)Complete Resolution of Ocular Pain at Day 4 Visit 4 (Day 4) maintained through Visit 6 (Day 15) 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
1. = Minimal
2. = Mild
3. = Moderate
4. = Moderately Severe
5. = Severe
Trial Locations
- Locations (35)
Apex Eye
🇺🇸Cincinnati, Ohio, United States
Sall Research Medical Center
🇺🇸Artesia, California, United States
Arizona Eye Center
🇺🇸Chandler, Arizona, United States
Cornea and Cataract Consultants of CA
🇺🇸Phoenix, Arizona, United States
Orange County Ophthalmology
🇺🇸Garden Grove, California, United States
Lugene Eye Institute
🇺🇸Glendale, California, United States
Inland Eye Specialists
🇺🇸Hemet, California, United States
United Medical Research Institute
🇺🇸Inglewood, California, United States
LoBue Laser and Eye Medical Center
🇺🇸Murrieta, California, United States
Pendleton Eye Center
🇺🇸Oceanside, California, United States
North Bay Eye Associates, Inc.
🇺🇸Petaluma, California, United States
Arch Health Partners
🇺🇸Poway, California, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Shasta Eye Medical Group, Inc
🇺🇸Redding, California, United States
Eye Center of Northern Colorado, PC
🇺🇸Fort Collins, Colorado, United States
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
Eye Associates of Fort Myers
🇺🇸Fort Myers, Florida, United States
Shettle Eye Research, Inc
🇺🇸Largo, Florida, United States
International Research Center
🇺🇸Tampa, Florida, United States
Chicago Cornea Consultants, Ltd.
🇺🇸Hoffman Estates, Illinois, United States
Jacksoneye, S. C.
🇺🇸Lake Villa, Illinois, United States
Great Lakes Eye Care
🇺🇸Saint Joseph, Michigan, United States
The Eye Care Institute
🇺🇸Louisville, Kentucky, United States
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
🇺🇸Washington, Missouri, United States
Minnesota Eye Consultants, PA
🇺🇸Bloomington, Minnesota, United States
Abrams Eye Institute
🇺🇸Las Vegas, Nevada, United States
Duke University Eye Center
🇺🇸Durham, North Carolina, United States
Roseburg Research Associates, LLC
🇺🇸Roseburg, Oregon, United States
Eye Care Specialists
🇺🇸Kingston, Pennsylvania, United States
Carolina Cataract & Laser Center
🇺🇸Ladson, South Carolina, United States
Texan Eye, PA / Keystone Research, Ltd
🇺🇸Austin, Texas, United States
The Cataract & Glaucoma Center
🇺🇸El Paso, Texas, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Kozlovsky Delay & Winter Eye Consultants, LLC Corona Research
🇺🇸San Antonio, Texas, United States
Carolina Eyecare Physicians, LLC
🇺🇸Mount Pleasant, South Carolina, United States