Phase 3
N=380
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation
Ocular Infections, Irritations and Inflammations
Bottom Line
View on ClinicalTrials.gov: NCT02163824 ↗Enrolled (actual)
380
Serious AEs
1.3%
Results posted
Dec 2020
Primary outcome: Primary: Resolution of Anterior Chamber Cells — 48; 39; 19 Participants — p=.0024
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- KPI-121 0.25% (Drug); KPI-121 1.0% (Drug); Vehicle of KPI-121 0.25% (Drug); Vehicle of KPI-121 1.0% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kala Pharmaceuticals, Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of Anterior Chamber Cells |
48; 39; 19 | .0024 sig |
| PRIMARY Resolution of Ocular Pain |
73; 67; 43 | .0019 sig |
| SECONDARY Anterior Chamber Cell Grade at Visit 5. |
0.7; 0.9; 1.0 | 0.0007 sig |
| SECONDARY Anterior Chamber Cell Grade at Visit 6. |
0.4; 0.5; 0.6 | 0.0391 sig |
| SECONDARY Ocular Pain Grades at Day 8. |
0.4; 0.4; 0.5 | 0.1953 |
| SECONDARY Ocular Pain Grades at Day 15. |
0.2; 0.2; 0.3 | 0.2589 |
Summary
The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery. The efficacy and safety of two different concentrations and two different dosing regimens of KPI-121 are also being assessed.
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.
Data sourced from ClinicalTrials.gov (NCT02163824). 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.