Evaluating CBT-004 for treating vascularized pinguecula
A Phase 2 Multicenter, Randomized, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of CBT-004 Ophthalmic Emulsion in Patients With Vascularized Pinguecula
PHASE2 · Cloudbreak Therapeutics, LLC · NCT04884256
This study is testing a new eye drop called CBT-004 to see if it can help people with vascularized pinguecula feel better and reduce the growth of blood vessels in their eyes.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cloudbreak Therapeutics, LLC (industry) |
| Locations | 1 site (Glendale, California) |
| Trial ID | NCT04884256 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multicenter, randomized, double-masked, vehicle-controlled study designed to assess the safety and efficacy of CBT-004 in patients with vascularized pinguecula. Participants will receive one drop of the assigned medication in the study eye three times a day for four weeks, followed by a four-week observation period. The study aims to determine the impact of CBT-004 on ocular symptoms and the vascularity of the pinguecula. Both the subjects and investigators will be blinded to the treatment to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a vascularized pinguecula and bothersome ocular symptoms.
Not a fit: Patients with uncontrolled systemic diseases or other active ocular conditions that may interfere with the study results will not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could significantly improve symptoms and reduce the vascularity associated with pinguecula, enhancing patients' quality of life.
How similar studies have performed: While there is limited information on similar studies, the approach of using a targeted treatment for ocular conditions shows promise based on previous research in ocular therapeutics.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Glendale, California
- Global Research Management — Glendale, California, United States (RECRUITING)
Study contacts
- Study coordinator: Bing Leng, MD
- Email: leng_bing@cloudbreaktherapeutics.com
- Phone: 19493952891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pinguecula