A Phase 2 interventional study of KPI-121 and Vehicle in Blepharitis, sponsored by Kala Pharmaceuticals, Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-11.
Sponsored by Kala Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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).
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 206 is above the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Kala Pharmaceuticals, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Drug: Vehicle
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
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.
Also known as: KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonate
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.
Also known as: KPI-121 0.25% Vehicle, Placebo
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).
Time frame: 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 1. mild 2. moderate 3. severe 4. very severe
Time frame: Visit 2 (Day 1) to Visit 4 (Day 15)
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).
Time frame: Visit 2 (Day 1) to Visit 6 (Day 29)
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 1. mild 2. moderate 3. severe 4. very severe
Time frame: 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 1. mild 2. moderate 3. severe 4. very severe
Time frame: 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 1. mild 2. moderate 3. severe 4. very severe
Time frame: Visit 2 (Day 1) to Visit 6 (Day 29)
| Milestone | Vehicle | KPI-121 0.25% Ophthalmic Suspension |
|---|---|---|
| Started | 101 | 104 |
| Completed | 96 | 101 |
| Not completed | 5 | 3 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Lost to follow-up | 1 | 0 |
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).
| score on a scale | Vehicle | KPI-121 0.25% Ophthalmic Suspension |
|---|---|---|
| Change From Baseline in Ocular Discomfort | -4.1 ± 13.8 | -2.4 ± 16.7 |
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 1. mild 2. moderate 3. severe 4. very severe
| score on a scale | Vehicle | KPI-121 0.25% Ophthalmic Suspension |
|---|---|---|
| Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline | -0.5 ± 0.7 | -04 ± 0.7 |
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).
| score on a scale | Vehicle | KPI-121 0.25% Ophthalmic Suspension |
|---|---|---|
| Change From Baseline in Ocular Discomfort | -8.2 ± 17.1 | -5.0 ± 15.8 |
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 1. mild 2. moderate 3. severe 4. very severe
| score on a scale | Vehicle | KPI-121 0.25% Ophthalmic Suspension |
|---|---|---|
| Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline | -0.4 ± 0.7 | -0.6 ± 0.7 |
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 1. mild 2. moderate 3. severe 4. very severe
| score on a scale | Vehicle | KPI-121 0.25% Ophthalmic Suspension |
|---|---|---|
| Change From Baseline in Posterior Lid Margin Hyperemia | -0.56 ± 0.72 | -0.55 ± 0.64 |
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 1. mild 2. moderate 3. severe 4. very severe
| score on a scale | Vehicle | KPI-121 0.25% Ophthalmic Suspension |
|---|---|---|
| Change From Baseline in Posterior Lid Margin Hyperemia | -0.63 ± 0.76 | -0.65 ± 0.8 |
Collected over Adverse events were collected from the time a subject signed the informed consent at Visit 1 until they exited the study at Visit 6.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle | 0/101 (0%) | 0/101 (0%) | 8/101 (7.9%) |
| KPI-121 0.25% Ophthalmic Suspension | 0/104 (0%) | 0/104 (0%) | 8/104 (7.7%) |
| Event | Vehicle | KPI-121 0.25% Ophthalmic Suspension |
|---|---|---|
| Instillation site painGeneral disorders | 8/101 | 8/104 |
| Age, Continuous(years) | Vehicle | KPI-121 0.25% Ophthalmic Suspension | Total |
|---|---|---|---|
| Mean | 58.6 ± 13.13 | 60.2 ± 11.28 | 59.4 ± 12.22 |
| Sex: Female, Male(Participants) | Vehicle | KPI-121 0.25% Ophthalmic Suspension | Total |
|---|---|---|---|
| Female | 72 | 62 | 134 |
| Male | 29 | 42 | 71 |
| Ethnicity (NIH/OMB)(Participants) | Vehicle | KPI-121 0.25% Ophthalmic Suspension | Total |
|---|---|---|---|
| Hispanic or Latino | 28 | 35 | 63 |
| Not Hispanic or Latino | 73 | 69 | 142 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Vehicle | KPI-121 0.25% Ophthalmic Suspension | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 6 | 6 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 13 | 26 |
| White | 80 | 84 | 164 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Vehicle | KPI-121 0.25% Ophthalmic Suspension | Total |
|---|---|---|---|
| United States | 101 | 104 | 205 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Jul 2014, a primary completion of Dec 2015 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2021, 5 years 1 month after primary completion. A results delay was requested in Oct 2016.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Loteprednol Etabonate
Kala Pharmaceuticals, Inc.