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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease |
|
| KPI-121 0.25% Ophthalmic Suspension | Active Comparator | KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KPI-121 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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
| Visit 2 (Day 1) to Visit 4 (Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Abrams, MD | Abrams Eye Center | Principal Investigator |
| Damien Goldberg, MD | Wolstan & Goldberg Eye Associates | Principal Investigator |
| Jodi Luchs, MD | South Shore Eye Center, LLP | Principal Investigator |
| Kelly Nichols, OD, PhD | UAB School of Optometry | Principal Investigator |
| Steven Rauchman, MD | North Valley Eye Medical Group | Principal Investigator |
| Kenneth Sall, MD | Sall Research Medical Center | Principal Investigator |
| John Sheppard, MD | Virginia Eye Consultants | Principal Investigator |
| Joseph Tauber, MD | Tauber Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB School of Optometry | Birmingham | Alabama | 35294-0010 | United States | ||
| Sall Research Medical Center |
206 subjects were randomized, 1 of which were not included in any analysis population as the individual did not receive randomized treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease 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. |
| FG001 | KPI-121 0.25% Ophthalmic Suspension | KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | ITT population | Posted | Mean | Standard Deviation | score on a scale | Visit 2 (Day 1) to Visit 4 (Day 15) |
|
Adverse events were collected from the time a subject signed the informed consent at Visit 1 until they exited the study at Visit 6.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle | Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Development | Kala Pharmaceuticals, Inc | 781-996-5252 | Results003@kalarx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2015 | Nov 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001762 | Blepharitis |
| D010146 | Pain |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
|
| Vehicle | Drug | 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. |
|
|
| 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
|
| Visit 2 (Day 1) to Visit 6 (Day 29) |
| 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
| Visit 2 (Day 1) to Visit 4 (Day 15) |
| 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
| Visit 2 (Day 1) to Visit 6 (Day 29) |
| Artesia |
| California |
| 90701 |
| United States |
| North Valley Eye Medical Group | Mission Hills | California | 91345 | United States |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| South Shore Eye Center, LLP | Wantagh | New York | 11793 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| BG001 | KPI-121 0.25% Ophthalmic Suspension | KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | KPI-121 0.25% Ophthalmic Suspension | KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease 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. |
|
|
| 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
| m1ITT- a subset of the ITT population with greater baseline hyperemia | Posted | Mean | Standard Deviation | score on a scale | 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). | ITT population | Posted | Mean | Standard Deviation | score on a scale | 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
| m1ITT- a subset of the ITT population with greater baseline hyperemia. m1ITT population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | 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
| ITT population | Posted | Mean | Standard Deviation | score on a scale | 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
| ITT population | Posted | Mean | Standard Deviation | score on a scale | Visit 2 (Day 1) to Visit 6 (Day 29) |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 8 |
| 101 |
| EG001 | KPI-121 0.25% Ophthalmic Suspension | KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease 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. | 0 | 104 | 0 | 104 | 8 | 104 |
The agreement between the Principal Investigator and the Sponsor restricts the PI's rights to discuss or publish trial results until after the first to occur of the following:
(a) publication of such multi-center clinical trial results; (b) notification by sponsor that such a multi-center clinical trial submission is no longer planned; or ( c) the eighteen ( 18) month anniversary of the completion, abandonment or termination of such multi-center clinical trial.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |