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Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04884256
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : January 29, 2024
Sponsor:
Information provided by (Responsible Party):
Cloudbreak Therapeutics, LLC

Tracking Information
First Submitted Date  ICMJE May 5, 2021
First Posted Date  ICMJE May 12, 2021
Last Update Posted Date January 29, 2024
Actual Study Start Date  ICMJE December 21, 2023
Estimated Primary Completion Date August 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2024)		 Change from Baseline in conjunctival hyperemia grade at Day 28 (Week 4). [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2021)		 Incidence of treatment-emergent adverse events [ Time Frame: 1 month ]
Visual acuity, biomicroscopy, intraocular pressure, ophthalmoscopy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2024)		 Change from Baseline conjunctival hyperemia digital image grade at Days 7 (Week 1) and 56 (Week 8). [ Time Frame: 2 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2021)		 Pinguecula Vascularity [ Time Frame: 1 month ]
Change of the pinguecula vascularity grade from baseline (Day 1) at Week 4
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula
Official Title  ICMJE A Phase 2 Multicenter, Randomized, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of CBT-004 Ophthalmic Emulsion in Patients With Vascularized Pinguecula
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pinguecula
Intervention  ICMJE Drug: CBT-004
Dose response study
Study Arms  ICMJE
  • Placebo Comparator: CBT-004
    Intervention: Drug: CBT-004
  • Experimental: 0.05% CBT-004
    Intervention: Drug: CBT-004
  • Experimental: 0.075% CBT-004
    Intervention: Drug: CBT-004
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2021)		 75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2025
Estimated Primary Completion Date August 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bing Leng, MD 19493952891 leng_bing@cloudbreaktherapeutics.com
Contact: Van Dinh, MBA 19493945308 dinh_van@cloudbreaktherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04884256
Other Study ID Numbers  ICMJE CBT-CS103
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Cloudbreak Therapeutics, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cloudbreak Therapeutics, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cloudbreak Therapeutics, LLC
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP