Meibomian Gland Dysfunction
Conditions
Brief 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
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
Interventions
DRUGCBT-006
ophthalmic solution
Sponsors
Cloudbreak Therapeutics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with MGD in both eyes and meet the following: 1. Ocular discomfort Score (ODS) ≥ 2 2. Visual Analog Scale (VAS) level is 35-90% for at least 1 of the 7 categories 3. Total Cornea staining grade ≥ 3 4. 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 5. TBUT ≤ 5 s 6. Schirmer I Test (anaesthetized) ≥ 5 mm/5 min in study eye 7. 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.
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP of Study Eye Related to Safety | 12 weeks | Intraocular Pressure of study eye related to safety |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBT-006 Vehicle
CBT-006: ophthalmic solution | 32 |
| CBT-006 Lower Concentration lower concentration dose
CBT-006: ophthalmic solution | 30 |
| CBT-006 Higher Concentration higher concentration dose
CBT-006: ophthalmic solution | 30 |
| Total | 92 |
Baseline characteristics
| Characteristic | CBT-006 | Total | CBT-006 Higher Concentration | CBT-006 Lower Concentration |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 31 Participants | 6 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 61 Participants | 24 Participants | 18 Participants |
| Age, Continuous | 61.9 years STANDARD_DEVIATION 6.98 | 58.6 years STANDARD_DEVIATION 11.65 | 52.3 years STANDARD_DEVIATION 13.23 | 61.3 years STANDARD_DEVIATION 11.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 23 Participants | 9 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 69 Participants | 21 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Intraocular Pressure of study eye related to safety | 16.328 mmHg STANDARD_DEVIATION 2.1425 | 16.282 mmHg STANDARD_DEVIATION 0.21359 | 16 mmHg STANDARD_DEVIATION 2.6781 | 16.517 mmHg STANDARD_DEVIATION 2.5342 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 14 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 16 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 62 Participants | 17 Participants | 23 Participants |
| Region of Enrollment United States | 32 participants | 92 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 18 Participants | 50 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Male | 14 Participants | 42 Participants | 18 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 4 / 32 | 3 / 30 | 4 / 30 |
| serious Total, serious adverse events | 0 / 32 | 0 / 30 | 0 / 30 |
Outcome results
Primary
IOP of Study Eye Related to Safety
Intraocular Pressure of study eye related to safety
Time frame: 12 weeks
Population: Safety Population Study eye
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-006 Vehicle | IOP of Study Eye Related to Safety | 16.547 mmHg | Standard Deviation 2.0882 |
| CBT-006 Lower Concentration | IOP of Study Eye Related to Safety | 16.328 mmHg | Standard Deviation 2.623 |
| CBT-006 Higher Concentration | IOP of Study Eye Related to Safety | 16.241 mmHg | Standard Deviation 2.6647 |