Conditions: Meibomian Gland Dysfunction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 92
Healthy volunteers: no

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

Arms:
arm 1: Vehicle arm 2: lower concentration dose arm 3: higher concentration dose

Interventions: intervention 1: CBT-006
Intervention descriptions: intervention 1: ophthalmic solution

Protocol document:
Prot_SAP_000.pdf: 
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CLOUDBREAK THERAPEUTICS 
 
Protocol-short 
 
A Phase 2 multicenter, double-masked, randomized, vehicle-controlled, parallel study 
to evaluate the safety, efficacy and pharmacokinetics of CBT-008 ophthalmic solution in 
patients with Meibomian Gland Dysfunction associated Dry Eye Disease (MGD-DED) 
 
Protocol Number:   
 
 
 
 
 
 
CBT-CS102 
ClinicalTrials.gov Identifier  
 
 
 
 
NCT04884243 
Name of Investigational Product:   
 
 
CBT-006 Ophthalmic Solution 
Governing IRB/IEC:  
 
 
 
 
 
 
Sterling IRB 
Sponsor:   
 
 
 
 
 
 
 
 
 
Cloudbreak Therapeutics, LLC 
15615 Alton Parkway, Suite 450 
Irvine, CA 92618, USA 
Emergency Phone Numbers:   
 
 
 
1-949-678-9752 
SAE Reporting Fax Number:   
 
 
 
1-949-271-6302 
SAE Reporting Email Address:  
 
 
 
leng_bing@cloudbreaktherapeutics.com 
Medical Safety Monitor Contact:   
 
 
Ken Sall, M.D. 
Tel (office): 1-562-754-2947 
Email: drsall@sallresearch.com 
 
 
 
 
Date:  
 
 
 
 
 
 
 
 
 
 
February 10, 2023 
 
 


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Study Number: CBT-CS102 
Name of Sponsor:  Cloudbreak Therapeutics 
Name of Finished Product: Ophthalmic Solution of CBT-006  
Name of Active Ingredient: CBT-006 
Title of Study: A Phase 2 multicenter, double-masked, randomized, vehicle-controlled, parallel study to 
evaluate the safety, efficacy and pharmacokinetics of CBT-006 ophthalmic solution in patients with 
Meibomian Gland Dysfunction associated Dry Eye Disease (MGD-DED) 
Study Period:  
Study Initiation Date (First Subject Enrolled): 21 July 2021 
Study Completion Date (Last Subject Completed): 24 September 2022 
Phase of Development: Phase 2 
Objectives:   
To evaluate the safety and effect of CBT-006 ophthalmic solution dosed in both eyes topically TID for 3 
months in patients with MGD-DED 
Methodology:   
Strategy:  
 
Evaluate the ocular and systemic safety profiles of CBT-006 ophthalmic solution in patients with 
MGD-DED 
 
Assess whether CBT-006 is efficacious in improving the symptoms. 
 
Assess whether CBT-006 is efficacious in improving the signs. 
Plan:  
A multicenter, double-masked, randomized, vehicle-controlled and parallel study is designed with 3 
months TID repeat ocular dosing of vehicle, lower and higher concentration of CBT-006. Ophthalmic and 
physical examinations will be performed at screening, day 1 and weeks 2, 4, 8, 12.  
Number of Subjects: 90  
Diagnosis and Main Criteria for Eligibility: 
Major Inclusion Criteria 
 
Diagnosed with MGD in both eyes and meet the following: 
a. 
ODS ≥ 2  
b. VAS score between 35-90% for at least 1 of the 7 categories 
c. 
Total Cornea staining grade ≥ 3  
d. Total meibum quality score (MQS) between 6-17 from the sum of the 6 lower eyelid 
central glands in at least one lower eyelid  
e. 
FTBUT ≤ 5 s  
f. 
Schirmer I Test (anaesthetized) ≥ 5 mm after 5 minutes in study eye 
g. BCVA LogMAR ≥ +0.7 in each eye. 


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 
Willing to withhold the use of artificial tears and eye lubricants during the treatment phase. 
 
≥ 18 years old 
 
Able to provide written informed consent and comply with study assessments for the full duration 
of the study. 
Major Exclusion Criteria 
 
Uncontrolled systemic disease in the opinion of the Investigator 
 
Active allergy, infection, or ocular surface inflammatory disease unrelated to MGD 
 
History of ocular herpes disease in either eye 
 
Ocular surgery history within 6 months  
 
Patients taking eye lubricants must stop after Day 1 visit 
 
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. Patients must have 
discontinued use of ophthalmic medications for at least 2 weeks prior to the screening visit, the 
use of 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 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 
Test Product, Dose and Mode of Administration, Batch Number: CBT-006 ophthalmic solution of 
vehicle, lower and higher concentration dosed in both eyes topically TID.  
Reference Therapy, Dose and Mode of Administration, Batch Number: Not applicable. 
Duration of Treatment: 3 months of continuous ocular dosing 
Study Measurements:  
Safety (Primary): 
 
Ocular: ocular symptoms, visual acuity, intraocular pressure, biomicroscopy, ophthalmoscopy 
Systemic: vital signs, pregnancy test, and adverse event reporting 
Efficacy (Co-Primary):  
 
Comparison between drug-treated and vehicle-treated groups on change of mean ODS at Week 12 
from Day 1 baseline (questionnaire);  
 
Comparison between drug-treated and vehicle-treated groups on change of mean cornea staining 
grade at Week 12 from Day 1 baseline (By site PI);  
Efficacy (Secondary):  


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Comparison between drug-treated and vehicle-treated groups on change of mean ODS at Weeks 2, 4, 8 
from Day 1 baseline (questionnaire);  
Comparison between drug-treated and vehicle-treated groups on change of mean VAS at Weeks 2, 4, 8, 12 
from Day 1 baseline (questionnaire); 
Comparison between drug-treated and vehicle-treated groups on change of mean cornea staining grade at 
Weeks 2, 4, 8 from Day 1 baseline (By site PI);  
Comparison between drug-treated and vehicle-treated groups on change at Weeks 2, 4, 8, 12 from Day 1 
baseline. 
Statistical Methods: One database lock is planned for the study. The final analysis will be performed 
after study completion.  
 
In general, continuous data will be summarized with descriptive statistics (number of patients, mean, 
standard deviation, median, minimum and maximum) and will be analyzed using analysis of variance 
(ANOVA) or covariance (ANCOVA) techniques with contrasts for between-group comparisons, and 
paired t-tests for within-group analyses. Categorical variables will be summarized by sample size (N), 
frequency count and percent, and analyzed using Pearson’s chi-square test or Fisher’s exact test. Ordinal 
variables will be analyzed using the ordinal regression model with contrasts for between-group 
comparisons and the signed-rank test for within-treatment comparisons. Two between-group comparisons 
are planned: CBT-006 lower concentration vs vehicle and CBT-006 higher concentration vs vehicle.  All 
hypothesis testing will be performed with a significance level of 5%, 2-sided, without adjustment for 
multiple comparisons.   
 
 
Duration of Study Follow-Up: None 
 


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Schedule of Events 
Study Procedures 
Visit 1 
Screening 
Day -14±2
Visit 2 
Day 1a 
 
Visit 3 
Week 2 
(± 3 days)
Visit 4 
Week 4 
(± 5 days)
Visit 5 
Week 8 
(± 7 days)
Visit 6 
Week 12 
(± 7 days)
Informed 
Consent/Authorization 
X 
 
 
 
 
 
Subject ID Assignment 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical / Ocular History 
X 
 
 
 
 
 
Concomitant 
Medications/Concurrent 
Procedures 
X 
X 
X 
X 
X 
X 
Vital Sign measurements 
(blood pressure, heart rate, 
body temperature) 
X 
X 
X 
X 
X 
X 
Pregnancy test, if applicable 
X 
X 
X 
X 
X 
X 
VAS assessment  
X 
X 
X 
X 
X 
X 
ODS assessment 
X 
X 
X 
X 
X 
X 
BLISS assessment 
X 
X 
X 
X 
X 
X 
Best-Corrected Visual Acuity
X 
X 
 
X 
 
X 
Intraocular Pressure 
X 
X 
 
X 
 
X 
Biomicroscopy 
X 
X 
X 
X 
X 
X 
Slit-lamp assessment 
including MQS and lid 
margin grading 
X 
X 
X 
X 
X 
X 
TBUT 
X 
X 
X 
X 
X 
X 
Cornea staining grading 
X 
X 
X 
X 
X 
X 
Schirmer I test 
(anaesthetized, last to 
perform prior to 
ophthalmoscopy) 
X 
X 
X 
X 
X 
X 
Ophthalmoscopy (dilated) 
X 
 
 
 
 
X 
Query for Serious Medical 
Events/Adverse Events 
X 
X 
X 
X 
X 
X 
Randomization 
 
X 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
X 
 
 
 
 
Study Medication 
 
Dispense 
 
Dispense+ 
Collect 
Dispense+ 
Collect 
Collect 
Exit 
 
 
 
 
 
X 
a 
All measurements at baseline Day 1 are prior to the instillation of first dose.