Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
Status: | Active, not recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | July 2014 |
End Date: | August 2016 |
A Phase II, Double-Masked, Randomized, Vehicle-Controlled Study to Evaluate the Effect of KPI-121 0.25% Ophthalmic Suspension on Signs and Symptoms of Inflammatory Meibomian Gland Disease
The primary purpose of this study is to determine the efficacy and safety of KPI-121
ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of
inflammatory meibomian gland disease.
ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of
inflammatory meibomian gland disease.
This is a Phase II, multicenter, double-masked, randomized, vehicle-controlled,
parallel-group study designed to evaluate the efficacy and safety of KPI-121 ophthalmic
suspension versus vehicle in subjects with signs and symptoms of inflammatory meibomian
gland disease. The product will be studied over 28 days, with 1-2 drops instilled in each
eye four times daily (QID).
parallel-group study designed to evaluate the efficacy and safety of KPI-121 ophthalmic
suspension versus vehicle in subjects with signs and symptoms of inflammatory meibomian
gland disease. The product will be studied over 28 days, with 1-2 drops instilled in each
eye four times daily (QID).
Inclusion Criteria:
Have a documented clinical diagnosis of inflammatory meibeomian gland disease in both
eyes.
Exclusion Criteria:
- Known hypersensitivity/contraindication to study product(s) or components.
- Be currently receiving treatment for glaucoma, have history of or current glaucoma,
or an IOP over 21mmHg at Visit 1 (Screening) or Visit 2 (Randomization).
- Be unwilling to discontinue warm compress therapy, lid expression, or lid massage 14
days prior to Day 1 and for the duration of the study.
- 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.
- Have had ocular surgery in the past 90 days or require ocular surgery during the
study.
- In the opinion of Investigator or study coordinator, be unwilling or unable to comply
with study protocol or unable to successfully instill eye drops.
We found this trial at
8
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