Meibomian Gland Dysfunction
Conditions
Brief 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
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 1. 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 2. Control Treatment CBT-008 vehicle 3. 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. 4. 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.
Interventions
DRUGCBT-008
Treat MGD
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 80 Years
Healthy volunteers
Yes
Inclusion criteria
Stage 1 inclusion criteria * • Diagnosed with MGD in both eyes and meet the following: 1. Ocular discomfort Score (ODS) ≥ 2 (No discomfort = 0, slight discomfort = 1, mild discomfort = 2, moderate discomfort = 3, severe discomfort = 4) 2. Visual Analog Scale (VAS) level is 35-90% for at least 1 of the 7 categories 3. Total Cornea staining grade ≥ 3 (NEI scheme with max score = 15) 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 (0-3 scale with max total = 18). 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. Stage 2 inclusion criteria 1. Patients who completed the Stage 1 Exit Visit for at least 1 month or healthy volunteers 2. At least 18 years of age at time of consent and able to provide written informed consent
Exclusion criteria
Stage 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP Related to Safety | 4 weeks | Intraocular Pressure for study eye |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBT-008 Vehicle Vehicle
CBT-008: ophthalmic solution | 32 |
| CBT-008 Lower Concentration Ophthalmic Solution lower concentration dose
CBT-008: ophthalmic solution | 31 |
| CBT-008 Higher Concentration Ophthalmic Solution higher concentration dose
CBT-008: ophthalmic solution | 32 |
| Total | 95 |
Baseline characteristics
| Characteristic | CBT-008 Vehicle | Total | CBT-008 Higher Concentration Ophthalmic Solution | CBT-008 Lower Concentration Ophthalmic Solution |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 34 Participants | 13 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 61 Participants | 19 Participants | 19 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 15.67 | 60.2 years STANDARD_DEVIATION 13.7 | 62.6 years STANDARD_DEVIATION 13.8 | 61.5 years STANDARD_DEVIATION 10.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 20 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 75 Participants | 28 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 | 15.844 mmHg STANDARD_DEVIATION 2.9415 | 16.098 mmHg | 16.078 mmHg STANDARD_DEVIATION 2.3352 | 16.371 mmHg STANDARD_DEVIATION 2.1015 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 18 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 17 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 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 | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 58 Participants | 19 Participants | 20 Participants |
| Region of Enrollment United States | 32 participants | 95 participants | 32 participants | 31 participants |
| Sex: Female, Male Female | 25 Participants | 65 Participants | 23 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 30 Participants | 9 Participants | 14 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 / 31 | 0 / 32 |
| other Total, other adverse events | 3 / 32 | 5 / 31 | 8 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 | 0 / 32 |
Outcome results
Primary
IOP Related to Safety
Intraocular Pressure for study eye
Time frame: 4 weeks
Population: Safety Population Study eye
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-008 Ophthalmic Solution | IOP Related to Safety | 15.906 mmHg | Standard Deviation 3.086 |
| CBT-008 Lower Concentration | IOP Related to Safety | 16.452 mmHg | Standard Deviation 2.6999 |
| CBT-008 Higher Concentration | IOP Related to Safety | 16.469 mmHg | Standard Deviation 2.2823 |