Phase 3
Completed N=520
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
Post Surgical Ocular Inflammation and Pain
Source: ClinicalTrials.gov NCT02793817 ↗
Enrolled (actual)
520
Serious AEs
0.6%
Results posted
Apr 2019
Primary outcomePrimary: Complete Resolution of Anterior Chamber (AC) Cells at Day 8 — 54; 32 Participants — p=0.0105
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Resolution of Anterior Chamber (AC) Cells at Day 8 |
54; 32 | 0.0105 sig |
| PRIMARY Complete Resolution of Ocular Pain at Day 8 |
149; 96 | <0.0001 sig |
| SECONDARY Complete Resolution of Ocular Pain at Day 4 |
109; 64 | <0.0001 sig |
| SECONDARY Complete Resolution of Anterior Chamber (AC) Flare at Day 4 |
113; 63 | <0.0001 sig |
| SECONDARY Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4 |
-0.7; -0.5 | 0.0078 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02793817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.