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

NCT ID: NCT04884243

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-05
• Study Completion Date: 2023-08-17

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

Conditions

Meibomian Gland Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CBT-006

Vehicle

Group Type: PLACEBO_COMPARATOR

CBT-006

Intervention Type: DRUG

ophthalmic solution

CBT-006 lower concentration

lower concentration dose

Group Type: EXPERIMENTAL

CBT-006

Intervention Type: DRUG

ophthalmic solution

CBT-006 higher concentration

higher concentration dose

Group Type: EXPERIMENTAL

CBT-006

Intervention Type: DRUG

ophthalmic solution

Interventions

CBT-006

ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

not apply

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cloudbreak Therapeutics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rong Yang

Role: STUDY_DIRECTOR

Cloudbreak Therapeutics, LLC

Locations

Eye Research Foundation

Newport Beach, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CBT-CS102

Identifier Type: -

Identifier Source: org_study_id