- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884243
Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction
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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Newport Beach, California, United States, 92663
- Eye Research Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
- 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.
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: CBT-006
Vehicle
|
ophthalmic solution
Other Names:
|
Experimental: CBT-006 lower concentration
lower concentration dose
|
ophthalmic solution
Other Names:
|
Experimental: CBT-006 higher concentration
higher concentration dose
|
ophthalmic solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IOP of Study Eye Related to Safety
Time Frame: 12 weeks
|
Intraocular Pressure of study eye related to safety
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ocular discomfort score (0-4)
Time Frame: 3 months
|
Change of the ocular discomfort score from baseline (Day 1) at Week 12; Score 0 is the most comfortable and 4 is the least comfortable
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rong Yang, Cloudbreak Therapeutics, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBT-CS102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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