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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884243
• Other study ID #: CBT-CS102
• Status: Completed
• Phase: Phase 2
• Start date: September 5, 2021
• Est. completion date: August 17, 2023

Study information

• Verified date: August 2023
• Source: Cloudbreak Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 17, 2023
• Est. primary completion date: August 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• CBT-006
ophthalmic solution

Locations

Country	Name	City	State
United States	Eye Research Foundation	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Cloudbreak Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP of Study Eye Related to Safety	Intraocular Pressure of study eye related to safety	12 weeks