- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884256
Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula
A Phase 2 Multicenter, Randomized, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of CBT-004 Ophthalmic Emulsion in Patients With Vascularized Pinguecula
STUDY DESIGN:
Structure:
Multicenter, randomized, double-masked, vehicle-controlled, parallel-group study.
Duration of Treatment:
4 weeks of study treatment with 4 weeks follow-up observations.
Control:
Vehicle for CBT-004 (hereafter referred to as Vehicle).
Masking:
Subjects, Investigators, Study Monitors and the Independent Image Reading Center are all masked to the study medications.
Dosage/Dose regimen:
One drop of the assigned study medication will be administered in the study eye TID for 4 weeks. The study eye is defined as the qualified eye (i.e., the eye meeting the inclusion criterion for vascularized pinguecula). If both eyes are qualified, then the eye with the more severe vascularity grade at Visit 1 will be the study eye.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Bing Leng, MD
- Phone Number: 19493952891
- Email: leng_bing@cloudbreaktherapeutics.com
Study Contact Backup
- Name: Van Dinh, MBA
- Phone Number: 19493945308
- Email: dinh_van@cloudbreaktherapeutics.com
Study Locations
-
-
California
-
Glendale, California, United States, 91204
- Recruiting
- Global Research Management
-
Contact:
- Logi El-Harazi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pinguecula with a vascularity grade ≥ 3 on a 5-point (0-4) scale.
- Ocular bothersome questionnaire score ≥ 2 on a 5-point (0-4) scale.
- ≥ 18 years of age.
- 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 ocular disease other than pinguecula that may confound the study data, including but not limited to severe dry eye disease, pterygium, uncontrolled blepharitis, anterior membrane dystrophy, Salzmann's, glaucoma, or active ocular infection.
- History of ocular herpes disease, iritis/uveitis, in either eye.
- Any ocular surgical procedure within the last 3 months or anticipated ocular surgery during the study, in either eye.
- Anticipated wearing of contact lenses during any portion of the study. Patients, who wear soft contact lenses should discontinue wearing them at least 7 days prior to Day 1 visit. Patients wearing rigid gas permeable or hard contact lenses should discontinue wearing them at least 3 weeks prior to Day 1 visit.
- Female patients who are pregnant, nursing, or planning a pregnancy during the study.
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to entry into this study.
- History of myocardial infarction or stroke.
- 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.
- Known allergy or sensitivity to the study medication(s) or its components.
- Current or anticipated use of topical ophthalmic medications in the study eye. Patients must have discontinued use of ophthalmic medications in the study eye for at least 2 weeks (4 weeks for Restasis® or Xiidra®) prior to Day 1 visit. Artificial tears are allowed in the study eye until 7 days prior to Visit 1 and should not be used during the treatment phase of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: CBT-004
|
Dose response study
|
Experimental: 0.05% CBT-004
|
Dose response study
|
Experimental: 0.075% CBT-004
|
Dose response study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in conjunctival hyperemia grade at Day 28 (Week 4).
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline conjunctival hyperemia digital image grade at Days 7 (Week 1) and 56 (Week 8).
Time Frame: 2 month
|
2 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBT-CS103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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