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

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

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.

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 States

    Active - Recruiting

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