Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation (Hawaii-1)
Ocular Infections, Irritations and Inflammations
About this trial
This is an interventional treatment trial for Ocular Infections, Irritations and Inflammations focused on measuring postsurgical, postoperative, ocular, cataract, inflammation, pain, corticosteroid
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.
Sites / Locations
- Sall Research Medical Center
- North Valley Eye Medical Group
- Martel Eye Medical Group
- Wolstan & Goldberg Eye Associates
- Clayton Eye Center
- Price Vision Group
- John-Kenyon American Eye Institute
- Taustine Eye Center
- Tauber Eye Center
- Tekwani Vision Center
- Ophthalmology Associates
- Ophthalmology Consultants
- Las Vegas Physicians Research Group
- Raymond Fong, MDPC
- Rochester Ophthalmological Group, PC
- Cornerstone Eye Care
- Cincinnati Eye Institute
- The Eye Center of Columbus
- Westside Research, LLC
- The Eye Clinic of Texas, Affiliate of Houston Eye Associates
- R&R Eye Research, LLC
- Kozlovsky Delay & Winter Eye Consultants, LLC
- Virginia Eye Consultants
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Placebo Comparator
Placebo Comparator
KPI-121 0.25% QID
KPI-121 1.0% BID
Vehicle of KPI-121 0.25%
Vehicle of KPI-121 1.0%
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
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.
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.