Last updated: January 25, 2024
Sponsor: Cloudbreak Therapeutics, LLC
Overall Status: Active - Recruiting
Phase
2
Condition
Eye Disease
Treatment
CBT-004
Clinical Study ID
NCT04884256
CBT-CS103
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thefull duration of the study.
Exclusion
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, uncontrolledblepharitis, anterior membrane dystrophy, Salzmann's, glaucoma, or active ocularinfection.
- History of ocular herpes disease, iritis/uveitis, in either eye.
- Any ocular surgical procedure within the last 3 months or anticipated ocular surgeryduring the study, in either eye.
- Anticipated wearing of contact lenses during any portion of the study. Patients, whowear 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 shoulddiscontinue 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 sucha 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 patientat significant risk, may confound the study results, or may interfere significantlywith 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 atleast 2 weeks (4 weeks for Restasis® or Xiidra®) prior to Day 1 visit. Artificialtears are allowed in the study eye until 7 days prior to Visit 1 and should not beused during the treatment phase of the study.
Study Design
Total Participants: 75
Treatment Group(s): 1
Primary Treatment: CBT-004
Phase: 2
Study Start date:
December 21, 2023
Estimated Completion Date:
October 01, 2025
Connect with a study center
Global Research Management
Glendale, California 91204
United StatesActive - Recruiting
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