Meibomian Gland DysfunctionPhase 2NCT05261386
Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction
A Phase 2 study testing CBT-008 in people with Meibomian Gland Dysfunction, run by Cloudbreak Therapeutics, LLC at 1 site in United States.
Trial summary
Study Design Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel group study Duration: 1 month of TID treatment Treatment Groups, Dosing, and Treatment Regimen Study Treatment: CBT-008 topical ophthalmic solution Control Treatment: CBT-008 vehicle Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- CBT-008
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to 29 Mar 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stage 1 inclusion criteria
- • Diagnosed with MGD in both eyes and meet the following:
- Ocular discomfort Score (ODS) ≥ 2 (No discomfort = 0, slight discomfort = 1, mild discomfort = 2, moderate discomfort = 3, severe discomfort = 4)
- Visual Analog Scale (VAS) level is 35-90% for at least 1 of the 7 categories
- Total Cornea staining grade ≥ 3 (NEI scheme with max score = 15)
- 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 (0-3 scale with max total = 18).
Show all 15Show fewer
- TBUT ≤ 5 s
- 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.
- Stage 2 inclusion criteria
- Patients who completed the Stage 1 Exit Visit for at least 1 month or healthy volunteers
- At least 18 years of age at time of consent and able to provide written informed consent
Who cannot join
- Stage 1 exclusion criteria
- 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
Show all 15Show fewer
- 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.)
- 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 Stage 2 exclusion criteria
- Females who were pregnant or nursing
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to entry into this study
- Previously randomized in the CBT-CS102 clinical trial and dosed with CBT-006
Trial locations and contacts
1 site in 1 country.
United States1 site
David Research Wirta
Newport Beach, California, 92663
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-008 in Patients With Meibomian Gland Dysfunction
Study Design
Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel group study Duration: 1 month of TID treatment Treatment Groups, Dosing, and Treatment Regimen Study Treatment: CBT-008 topical ophthalmic solution Control Treatment: CBT-008 vehicle
Read the detailed description
Structure Multicenter, randomized, double-masked, vehicle-controlled, parallel group study.
Duration Stage 1: 1 month Stage 2: 1 day (1 dose)
Treatment Groups, Dosing, and Treatment Regimen
- Study Treatment Stage 1: CBT-008 ophthalmic solution was administered as 1 drop OU TID Stage 2: CBT-008 ophthalmic solution was administered as 1 drop in the study eye
- Control Treatment CBT-008 vehicle
- Methods for Masking Study medication will be packaged in identical kits and will be labeled with medication kit numbers. The central randomization system will provide the site with a specific medication kit number for the patient corresponding to the treatment group assigned.
- Instructions for Storage, Use, and Administration Study medication will be supplied as preservative free-unit dose containers, where 1 mL of CBT-008 ophthalmic solution will be aseptically filled into 3 mL Low Density Polyethylene (LDPE) ophthalmic dropper bottles. Study medication should be stored at room temperature in a secure area at clinical sites and dispensed only to patients enrolled into the clinical study. Patients will be instructed to store study medication in a cool place at room temperature at home. Study medication will be administered TID, one drop, to both eyes. First instillation of study medication on the first day will be applied by subject or care provider with site staff's observation for training and supervision. During the rest of the study treatment, patients will self-administer the medication TID for 1 month.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- CBT-008
- 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-008Drug
Treat MGD
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator: CBT-008 | Placebo comparator | Vehicle Receives: Drug: CBT-008 |
| Experimental: CBT-008 lower concentration | Experimental | lower concentration dose Receives: Drug: CBT-008 |
| Experimental: CBT-008 higher concentration | Experimental | higher concentration dose Receives: Drug: CBT-008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP Related to Safety
Intraocular Pressure for study eye
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start4 Mar 2022
- Primary completion7 Sep 2022
- Study completion29 Mar 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cloudbreak Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bing Leng, MD, Study director, ADS Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261386
- Sponsor's protocol ID
- CBT-CS-105
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2022
- Last updated
- 24 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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-008 in Patients With Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT05261386
- Acronym / sponsor ID
- CBT-CS-105
- Conditions
- Meibomian Gland Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Cloudbreak Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 2 Mar 2022 (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: 1 month of TID treatment Treatment Groups, Dosing, and Treatment Regimen Study Treatment: CBT-008 topical ophthalmic solution Control Treatment: CBT-008 vehicle
Detailed description
Structure Multicenter, randomized, double-masked, vehicle-controlled, parallel group study.
Duration Stage 1: 1 month Stage 2: 1 day (1 dose)
Treatment Groups, Dosing, and Treatment Regimen
- Study Treatment Stage 1: CBT-008 ophthalmic solution was administered as 1 drop OU TID Stage 2: CBT-008 ophthalmic solution was administered as 1 drop in the study eye
- Control Treatment CBT-008 vehicle
- Methods for Masking Study medication will be packaged in identical kits and will be labeled with medication kit numbers. The central randomization system will provide the site with a specific medication kit number for the patient corresponding to the treatment group assigned.
- Instructions for Storage, Use, and Administration Study medication will be supplied as preservative free-unit dose containers, where 1 mL of CBT-008 ophthalmic solution will be aseptically filled into 3 mL Low Density Polyethylene (LDPE) ophthalmic dropper bottles. Study medication should be stored at room temperature in a secure area at clinical sites and dispensed only to patients enrolled into the clinical study. Patients will be instructed to store study medication in a cool place at room temperature at home. Study medication will be administered TID, one drop, to both eyes. First instillation of study medication on the first day will be applied by subject or care provider with site staff's observation for training and supervision. During the rest of the study treatment, patients will self-administer the medication TID for 1 month.
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 |
|---|---|---|
| Placebo Comparator: CBT-008 | Placebo comparator | Drug: CBT-008Vehicle |
| Experimental: CBT-008 lower concentration | Experimental | Drug: CBT-008lower concentration dose |
| Experimental: CBT-008 higher concentration | Experimental | Drug: CBT-008higher concentration dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Stage 1 inclusion criteria
- • Diagnosed with MGD in both eyes and meet the following:
- Stage 2 inclusion criteria
- Patients who completed the Stage 1 Exit Visit for at least 1 month or healthy volunteers
- At least 18 years of age at time of consent and able to provide written informed consent
Key exclusion criteria (15 listed)
- Stage 1 exclusion criteria
- Uncontrolled systemic disease in the opinion of the Investigator
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-008Treat MGD | Drug | Experimental: CBT-008 higher concentration, Experimental: CBT-008 lower concentration, Placebo Comparator: CBT-008 |
Primary outcome
IOP Related to Safety
Time frame: 4 weeks
Intraocular Pressure for study eye
Results and safety
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.
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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.
Bing Leng, MD study director
ADS 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-008 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 15 inclusion and 15 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 Related to Safety (time frame: 4 weeks). 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 24 Apr 2024.