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

Phase 2

Completed

Conditions: Meibomian Gland Dysfunction

Interventions: Drug: CBT-006

Registration Number: NCT04884243

Lead Sponsor: Cloudbreak Therapeutics, LLC

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

Inclusion Criteria

Diagnosed with MGD in both eyes and meet the following:
1. Ocular discomfort Score (ODS) ≥ 2
2. Visual Analog Scale (VAS) level is 35-90% for at least 1 of the 7 categories
3. Total Cornea staining grade ≥ 3
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
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.

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