Overview

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

Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kala Pharmaceuticals, Inc.
Treatments:
Loteprednol Etabonate
Criteria
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, 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.