Phase 2
N=205
Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
Blepharitis
Bottom Line
View on ClinicalTrials.gov: NCT02218489 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change From Baseline in Ocular Discomfort — -4.1; -2.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KPI-121 (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kala Pharmaceuticals, Inc.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ocular Discomfort |
-8.2; -5.0 | — |
| PRIMARY Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline |
-0.4; -0.6 | — |
| SECONDARY Change From Baseline in Ocular Discomfort |
-8.2; -5.0 | — |
| SECONDARY Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline |
-0.4; -0.6 | — |
| SECONDARY Change From Baseline in Posterior Lid Margin Hyperemia |
-0.63; -0.65 | — |
| SECONDARY Change From Baseline in Posterior Lid Margin Hyperemia |
-0.63; -0.65 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
Have a documented clinical diagnosis of inflammatory meibomian 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 (intraocular pressure) 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.
Data sourced from ClinicalTrials.gov (NCT02218489). 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.