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Keep this study
Lead
Kala Pharmaceuticals, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be if
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.
Clareo Health | Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
