Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain (NCT02793817) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
United States520 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Complete Resolution of Anterior Chamber (AC) Cells at Day 8