Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: CBT-006


Participation Criteria
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Eligibility Criteria
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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). 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CBT-006<br> | Drug: CBT-006<br>* Cyclodextrin<br>|
| Experimental: 2.5% CBT-006<br> | Drug: CBT-006<br>* Cyclodextrin<br>|
| Experimental: 10% CBT-006<br> | Drug: CBT-006<br>* Cyclodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events | Visual acuity, biomicroscopy, intraocular pressure, ophthalmoscopy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular discomfort score (0-4) | 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 |