BlepharitisPhase 2MauiNCT02218489
Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
A Phase 2 study testing KPI-121 in people with Blepharitis, run by Kala Pharmaceuticals, Inc. at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- KPI-121
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2014to Jun 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Sall Research Medical Center
Artesia, California, 90701
UAB School of Optometry
Birmingham, Alabama, 35294-0010
Abrams Eye Center
Cleveland, Ohio, 44115
Tauber Eye Center
Kansas City, Missouri, 64111
North Valley Eye Medical Group
Mission Hills, California, 91345
Virginia Eye Consultants
Norfolk, Virginia, 23502
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
South Shore Eye Center, LLP
Wantagh, New York, 11793
About this study
Official title: 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.
Read the detailed 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).
- Conditions
- Blepharitis
- Being tested
- KPI-121, Vehicle
- Keywords
- Pain, Corticosteroid, Meibomian Gland Disease, Blepharitis, Eyelid, Ocular Discomfort
- Medical subject headings
- Blepharitis, Pain, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPI-121Drug
Also called KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonate
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.
VehicleDrug
Also called KPI-121 0.25% Vehicle, Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease Receives: Drug: Vehicle |
| 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 Receives: Drug: KPI-121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
- mild
- moderate
- severe
- very severe
Measured: Visit 2 (Day 1) to Visit 4 (Day 15)
Secondary outcomes (4)
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).
Measured: 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
- mild
- moderate
- severe
- very severe
Measured: 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
- mild
- moderate
- severe
- very severe
Measured: 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
- mild
- moderate
- severe
- very severe
Measured: Visit 2 (Day 1) to Visit 6 (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kala Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Abrams, MD, Principal investigator, Abrams Eye CenterDamien Goldberg, MD, Principal investigator, Wolstan & Goldberg Eye AssociatesJodi Luchs, MD, Principal investigator, South Shore Eye Center, LLPKelly Nichols, OD, PhD, Principal investigator, UAB School of OptometrySteven Rauchman, MD, Principal investigator, North Valley Eye Medical GroupKenneth Sall, MD, Principal investigator, Sall Research Medical CenterJohn Sheppard, MD, Principal investigator, Virginia Eye ConsultantsJoseph Tauber, MD, Principal investigator, Tauber Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218489
- Sponsor's protocol ID
- KPI-121-C-003
- Acronym
- Maui
- Status last verified
- Jan 2021
- First submitted
- 13 Aug 2014
- Last updated
- 11 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02218489
- Acronym / sponsor ID
- Maui / KPI-121-C-003
- Conditions
- Blepharitis
- Keywords
- Pain, Corticosteroid, Meibomian Gland Disease, Blepharitis, Eyelid, Ocular Discomfort
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Kala Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Posted 11 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: VehicleVehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease |
| KPI-121 0.25% Ophthalmic Suspension | Active comparator | Drug: KPI-121KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KPI-121Also: KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonateKPI-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. | Drug | KPI-121 0.25% Ophthalmic Suspension |
| VehicleAlso: KPI-121 0.25% Vehicle, PlaceboThe 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. | Drug | Vehicle |
Primary outcome
Change From Baseline in Ocular Discomfort
Time frame: Visit 2 (Day 1) to Visit 4 (Day 15)
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).
Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline
Time frame: Visit 2 (Day 1) to Visit 4 (Day 15)
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
4 secondary outcomes
Change From Baseline in Ocular Discomfort
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
Time frame: Visit 2 (Day 1) to Visit 6 (Day 29)
Change From Baseline in Posterior Lid Margin Hyperemia
Time frame: Visit 2 (Day 1) to Visit 4 (Day 15)
Change From Baseline in Posterior Lid Margin Hyperemia
Time frame: Visit 2 (Day 1) to Visit 6 (Day 29)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Abrams, MD principal investigator
Abrams Eye Center
Damien Goldberg, MD principal investigator
Wolstan & Goldberg Eye Associates
Jodi Luchs, MD principal investigator
South Shore Eye Center, LLP
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KPI-121 in people with Blepharitis, run by Kala Pharmaceuticals, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Ocular Discomfort (time frame: Visit 2 (Day 1) to Visit 4 (Day 15)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.