Meibomian Gland DysfunctionPhase 2NCT04884243

Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction

A Phase 2 study testing CBT-006 in people with Meibomian Gland Dysfunction, run by Cloudbreak Therapeutics, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

STUDY DESIGN Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel group study. Duration: 3 months of TID treatment. Treatment Groups, Dosing, and Treatment Regimen: Study Treatment: CBT-006 topical ophthalmic solution Control Treatment: CBT-006 vehicle Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Meibomian Gland Dysfunction
What is being tested?: CBT-006
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 92 participants
Where: 1 siteUnited States
Study dates: 5 Sep 2021to 17 Aug 2023
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

Diagnosed with MGD in both eyes and meet the following:
Ocular discomfort Score (ODS) ≥ 2
Visual Analog Scale (VAS) level is 35-90% for at least 1 of the 7 categories
Total Cornea staining grade ≥ 3
Total meibum quality score (MQS) is between 6-17 from the sum of the 6 lower eyelid central glands in at least one lower eyelid
TBUT ≤ 5 s

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Schirmer I Test (anaesthetized) ≥ 5 mm/5 min in study eye
BCVA LogMAR ≥ +0.7 in each eye
All patients of both genders ≥ 18 years
Willing to withhold the use of artificial tears and lubricants during the treatment phase;
Able to provide written informed consent and comply with study assessments for the full duration of the study.

Who cannot join

Uncontrolled systemic disease in the opinion of the Investigator
Active allergies with symptoms that may confound the data, active ocular infection requiring treatment, or ocular surface inflammatory disease unrelated to MGD or DED, including chalazion, inflamed pinguecula, and viral illness
History of ocular herpes disease in either eye
Incisional ocular surgery within 6 months or ocular laser surgery within 3 months
Use of topical treatment of the eye/eyelid with antibiotics, NSAIDS, or vasoconstrictors to treat MGD or DED within 14 days of screening; steroids, cyclosporin A or lifitegrast within 28 days of screening
Current or anticipated use of other topical ophthalmic medications in the study eye. (Patients must have discontinued the use of ophthalmic medications in the study eye for at least 2 weeks prior to the screening visit, the use of diagnostic medications as part of the eye exam prior to screening and artificial tears is allowed.)

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Anticipated wearing of contact lenses during any portion of the study. (Patients, who wear soft contact lenses should discontinue wearing them at least 3 days prior to screening visit. Patients wearing rigid gas permeable or hard contact lenses should discontinue wearing them at least 3 weeks prior to screening visit.)
Active rosacea involving the eyelids within 60 days of screening
Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to entry into this study
Any condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
Female patients who are pregnant, nursing, or planning a pregnancy during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Eye Research Foundation
Newport Beach, California, 92663

Other trials in United States

About this study

Official title: A Phase 2 Multicenter, Double-masked, Randomized, Vehicle-controlled, Parallel Study to Evaluate the Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction

STUDY DESIGN

Structure:

Multicenter, randomized, double-masked, vehicle-controlled, parallel group study.

Duration:

3 months of TID treatment.

Treatment Groups, Dosing, and Treatment Regimen:

Study Treatment: CBT-006 topical ophthalmic solution Control Treatment: CBT-006 vehicle

Read the detailed description

Structure:

Multicenter, randomized, double-masked, vehicle-controlled, parallel group study.

Duration:

3 months of TID treatment.

Treatment Groups, Dosing, and Treatment Regimen:

Study Treatment: CBT-006 topical ophthalmic solution Control Treatment: CBT-006 vehicle

Conditions: Meibomian Gland Dysfunction
Being tested: CBT-006
Medical subject headings: Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBT-006Drug
Also called not apply
ophthalmic solution

Study groups in NCT04884243
Study group	Role	What they receive
CBT-006	Placebo comparator	Vehicle Receives: Drug: CBT-006
CBT-006 lower concentration	Experimental	lower concentration dose Receives: Drug: CBT-006
CBT-006 higher concentration	Experimental	higher concentration dose Receives: Drug: CBT-006

What is being measured

The primary outcome is the main question the study is designed to answer.

IOP of Study Eye Related to Safety
Intraocular Pressure of study eye related to safety
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 202117 Aug 2023

First posted12 May 2021
Study start5 Sep 2021
Primary completion17 Aug 2023
Study completion17 Aug 2023

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 Meibomian Gland DysfunctionStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04884243
Sponsor's protocol ID: CBT-CS102
Status last verified: Aug 2023
First submitted: 5 May 2021
Last updated: 24 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
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TearCare in Young Adults
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Autologous Serum Obtained by a Closed-Circuit Collection Device
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Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
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Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
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All Meibomian Gland Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Multicenter, Double-masked, Randomized, Vehicle-controlled, Parallel Study to Evaluate the Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction
ClinicalTrials.gov ID: NCT04884243
Acronym / sponsor ID: CBT-CS102
Conditions: Meibomian Gland Dysfunction
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Cloudbreak Therapeutics, LLCIndustry (pharma, biotech, devices)
Study start: 5 Sep 2021 (actual)
Primary completion: 17 Aug 2023 (actual)
Study completion: 17 Aug 2023 (actual)
First posted: 12 May 2021 (actual)
Results: Posted 24 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

STUDY DESIGN

Structure:

Multicenter, randomized, double-masked, vehicle-controlled, parallel group study.

Duration:

3 months of TID treatment.

Treatment Groups, Dosing, and Treatment Regimen:

Study Treatment: CBT-006 topical ophthalmic solution Control Treatment: CBT-006 vehicle

Detailed description

Structure:

Multicenter, randomized, double-masked, vehicle-controlled, parallel group study.

Duration:

3 months of TID treatment.

Treatment Groups, Dosing, and Treatment Regimen:

Study Treatment: CBT-006 topical ophthalmic solution Control Treatment: CBT-006 vehicle

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
CBT-006	Placebo comparator	Drug: CBT-006Vehicle
CBT-006 lower concentration	Experimental	Drug: CBT-006lower concentration dose
CBT-006 higher concentration	Experimental	Drug: CBT-006higher concentration dose

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Diagnosed with MGD in both eyes and meet the following:
All patients of both genders ≥ 18 years
Willing to withhold the use of artificial tears and lubricants during the treatment phase;
Able to provide written informed consent and comply with study assessments for the full duration of the study.

Key exclusion criteria (11 listed)

Uncontrolled systemic disease in the opinion of the Investigator
Active allergies with symptoms that may confound the data, active ocular infection requiring treatment, or ocular surface inflammatory disease unrelated to MGD or DED, including chalazion, inflamed pinguecula, and viral illness
History of ocular herpes disease in either eye
Incisional ocular surgery within 6 months or ocular laser surgery within 3 months
Use of topical treatment of the eye/eyelid with antibiotics, NSAIDS, or vasoconstrictors to treat MGD or DED within 14 days of screening; steroids, cyclosporin A or lifitegrast within 28 days of screening

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
CBT-006Also: not applyophthalmic solution	Drug	CBT-006, CBT-006 higher concentration, CBT-006 lower concentration

Primary outcome

IOP of Study Eye Related to Safety
Time frame: 12 weeks
Intraocular Pressure of study eye related to safety

Results and safety

Results posted to the registry on 24 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CBT-006	32	32
CBT-006 Lower Concentration	30	29
CBT-006 Higher Concentration	30	28

Primary outcome: IOP of Study Eye Related to Safety

Time frame: 12 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	CBT-006 Vehicle n = 32	CBT-006 Lower Concentration n = 30	CBT-006 Higher Concentration n = 30
Value	16.547 (2.0882)	16.328 (2.6230)	16.241 (2.6647)

Population analysed: Safety Population Study eye

Adverse events

Time frame: one year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBT-006	0 of 32 (0%)	4 of 32 (12.5%)	0 of 32
CBT-006 Lower Concentration	0 of 30 (0%)	3 of 30 (10%)	0 of 30
CBT-006 Higher Concentration	0 of 30 (0%)	4 of 30 (13.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Meibomian Gland Dysfunction

Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease

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.

Rong Yang study director

Cloudbreak Therapeutics, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CBT-006 in people with Meibomian Gland Dysfunction, run by Cloudbreak Therapeutics, LLC at 1 site 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 11 inclusion and 11 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 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 24 Apr 2024). 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?

IOP of Study Eye Related to Safety (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04884243.

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 24 Apr 2024.