Trials / Completed
CompletedNCT02793817
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 520 (actual)
- Sponsor
- Kala Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KPI-121 1% Ophthalmic Suspension dosed BID | |
| DRUG | Vehicle of KPI-121 Ophthalmic Suspension dosed BID |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2017-03-01
- Completion
- 2017-03-01
- First posted
- 2016-06-08
- Last updated
- 2020-12-16
- Results posted
- 2019-04-17
Locations
35 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02793817. Inclusion in this directory is not an endorsement.