Status:
COMPLETED
Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula
Lead Sponsor:
Cloudbreak Therapeutics, LLC
Conditions:
Pinguecula
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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. C...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04884256
Start Date
December 21 2023
End Date
May 30 2025
Last Update
June 5 2025
Active Locations (1)
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1
Global Research Management
Glendale, California, United States, 91204