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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pinguecula Drug: CBT-004 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Randomized, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of CBT-004 Ophthalmic Emulsion in Patients With Vascularized Pinguecula
Actual Study Start Date : December 21, 2023
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : October 1, 2025
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: CBT-004 Drug: CBT-004
Dose response study
Experimental: 0.05% CBT-004 Drug: CBT-004
Dose response study
Experimental: 0.075% CBT-004 Drug: CBT-004
Dose response study


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in conjunctival hyperemia grade at Day 28 (Week 4). [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Change from Baseline conjunctival hyperemia digital image grade at Days 7 (Week 1) and 56 (Week 8). [ Time Frame: 2 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884256


Contacts
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Contact: Bing Leng, MD 19493952891 leng_bing@cloudbreaktherapeutics.com
Contact: Van Dinh, MBA 19493945308 dinh_van@cloudbreaktherapeutics.com

Locations
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United States, California
Global Research Management Recruiting
Glendale, California, United States, 91204
Contact: Logi El-Harazi         
Sponsors and Collaborators
Cloudbreak Therapeutics, LLC
More Information
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Responsible Party: Cloudbreak Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04884256    
Other Study ID Numbers: CBT-CS103
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: January 29, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pinguecula
Conjunctival Diseases
Eye Diseases