search
Back to results

Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction

Primary Purpose

Meibomian Gland Dysfunction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CBT-008
Sponsored by
Cloudbreak Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Diagnosed with MGD in both eyes and meet the following:

    1. Ocular discomfort Score (ODS) ≥ 2 (No discomfort = 0, slight discomfort = 1, mild discomfort = 2, moderate discomfort = 3, severe discomfort = 4)
    2. Visual Analog Scale (VAS) level is 35-90% for at least 1 of the 7 categories
    3. Total Cornea staining grade ≥ 3 (NEI scheme with max score = 15)
    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 (0-3 scale with max total = 18).
    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

Sites / Locations

  • David Research Wirta

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo Comparator: CBT-008

Experimental: 2.5% CBT-008

Experimental: 10% CBT-008

Arm Description

CBT-008 vehicle ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.

2.5% CBT-008 ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.

10% CBT-008 ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse event
Visual acuity, biomicroscopy, intraocular pressure, ophthalmoscopy

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2022
Last Updated
January 25, 2023
Sponsor
Cloudbreak Therapeutics, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT05261386
Brief Title
Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
January 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cloudbreak Therapeutics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Comparator: CBT-008
Arm Type
Placebo Comparator
Arm Description
CBT-008 vehicle ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.
Arm Title
Experimental: 2.5% CBT-008
Arm Type
Experimental
Arm Description
2.5% CBT-008 ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.
Arm Title
Experimental: 10% CBT-008
Arm Type
Experimental
Arm Description
10% CBT-008 ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.
Intervention Type
Drug
Intervention Name(s)
CBT-008
Other Intervention Name(s)
Methyl-beta-Cyclodextrin
Intervention Description
Cyclodextrin
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse event
Description
Visual acuity, biomicroscopy, intraocular pressure, ophthalmoscopy
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Ocular discomfort score (0-4)
Description
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
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Leng, MD
Organizational Affiliation
ADS Therapeutics, LLC
Official's Role
Study Director
Facility Information:
Facility Name
David Research Wirta
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction

We'll reach out to this number within 24 hrs