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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02218489
Other study ID # KPI-121-C-003
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 2014
Est. completion date June 2016

Study information

Verified date January 2021
Source Kala Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 206
Est. completion date June 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
KPI-121
KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Vehicle
The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.

Locations

Country Name City State
United States Sall Research Medical Center Artesia California
United States UAB School of Optometry Birmingham Alabama
United States Abrams Eye Center Cleveland Ohio
United States Tauber Eye Center Kansas City Missouri
United States North Valley Eye Medical Group Mission Hills California
United States Virginia Eye Consultants Norfolk Virginia
United States Wolstan & Goldberg Eye Associates Torrance California
United States South Shore Eye Center, LLP Wantagh New York

Sponsors (1)

Lead Sponsor Collaborator
Kala Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Ocular Discomfort Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 4 (Day 15). Visit 2 (Day 1) to Visit 4 (Day 15)
Primary Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in subjects with greater baseline hyperemia at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:
0=normal
mild
moderate
severe
very severe
Visit 2 (Day 1) to Visit 4 (Day 15)
Secondary Change From Baseline in Ocular Discomfort Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 6 (Day 29). Visit 2 (Day 1) to Visit 6 (Day 29)
Secondary Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in the subgroup of subjects with greater hyperemia at baseline at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:
0=normal
mild
moderate
severe
very severe
Visit 2 (Day 1) to Visit 6 (Day 29)
Secondary Change From Baseline in Posterior Lid Margin Hyperemia Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:
0=normal
mild
moderate
severe
very severe
Visit 2 (Day 1) to Visit 4 (Day 15)
Secondary Change From Baseline in Posterior Lid Margin Hyperemia Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:
0=normal
mild
moderate
severe
very severe
Visit 2 (Day 1) to Visit 6 (Day 29)
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