Safety, Efficacy and Pharmacokinetics of CBT-008 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: 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
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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 CBT-008 ophthalmic solution is a sterile, preservative-free ophthalmic solution containing CBT-008 (2.5 and 10%), sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4. Control Treatment CBT-008 vehicle CBT-008 vehicle ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4. 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. 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.

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-008 in Patients With Meibomian Gland Dysfunction

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: CBT-008


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
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Placebo Comparator: CBT-008<br>CBT-008 vehicle ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4. | Drug: CBT-008<br>* Cyclodextrin<br>* Other names: Methyl-beta-Cyclodextrin;|
| Experimental: Experimental: 2.5% CBT-008<br>2.5% CBT-008 ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4. | Drug: CBT-008<br>* Cyclodextrin<br>* Other names: Methyl-beta-Cyclodextrin;|
| Experimental: Experimental: 10% CBT-008<br>10% CBT-008 ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4. | Drug: CBT-008<br>* Cyclodextrin<br>* Other names: Methyl-beta-Cyclodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse event | Visual acuity, biomicroscopy, intraocular pressure, ophthalmoscopy | 1 month | 

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 4; score 0 is the most comfortable and 4 is the least comfortable | 1 month |