A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    600
  • sponsor
    Cloudbreak Therapeutics, LLC
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Updated on 4 October 2022
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Summary

The objective is to evaluate the safety and efficacy of 0.1% and 0.2% CBT-001 emulsion dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.

Description

Clinical Hypotheses:

  1. CBT-001 dosed twice daily is more effective than vehicle in:
    • Reducing conjunctival hyperemia by demonstrating a statistically significant difference and clinically relevant improvement in the mean severity grade change from baseline on a 5-point scale.
    • Preventing pterygium progression, by (a) demonstrating a statistically significant and clinically relevant improvement on drug vs vehicle mean difference in the change in pterygium length from baseline as measured from the anterior edge of the limbus to the pterygium apex; and (b) demonstrating a statistically significant mean difference in improving subject-reported eye symptom score change from baseline.
  2. CBT-001 emulsion maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.

Details
Condition Pterygium
Treatment Vehicle, CBT-001
Clinical Study IdentifierNCT05456425
SponsorCloudbreak Therapeutics, LLC
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female at least 12 years of age at the time of consent
Female subjects must agree to use an acceptable method of contraception
Diagnostic Inclusion Criteria The conjunctival hyperemia grade, pterygium vascularity grade and pterygium length will be confirmed to meet criteria
Subject has a best-corrected visual acuity (BCVA) score equivalent (using a logarithmic (LogMar) visual acuity chart) to Snellen acuity of 20/200 or better in at least one eye at Screening and Baseline (Day 1)
Is in good general health as determined by the investigator from medical history and physical examination findings, non-fasting blood analysis (complete blood count [CBC] with differential, blood chemistry) within reference range or acceptable to the investigator prior to randomization. Note: For the screening laboratory evaluation, subjects may have laboratory tests repeated once for reassessment at the discretion of the investigator prior to randomization. The investigator must review the screening results to confirm subject qualification for study entry
Written informed assent/consent of the subject has been obtained prior to any study-related procedures. If a subject is younger than the legal age of consent per local laws, the subject's parent(s), guardian or legally authorized representative will provide written informed consent. The subject will provide age-appropriate verbal or written assent
Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (e.g, Written Authorization for Use and Release of Health and Research Study Information)

Exclusion Criteria

Subject has known uncontrolled systemic disease including cancer under active treatment
Active ocular infection or conjunctivitis
In the opinion of the investigator, subject has clinically significant corneal abnormalities other than pterygium or related to prior pterygium surgery that may affect the validity of the study findings
History of ocular herpes disease in either eye
Any retina disease that could affect visual acuity (e.g., age-related macular degeneration)
Any ocular surgery or procedure (except pterygium excision surgery) within the last 3 months, including eye lid surgery, and dissolvable long-term punctal plugs in eyes with pterygium
Female who is pregnant, nursing, or planning a pregnancy, or female of childbearing potential not using reliable means of contraception
Known allergy or sensitivity to the study medication(s) or its components
Finding of pseudo-pterygium, marginal corneal disease, ocular neoplasia (e.g., carcinoma in situ, squamous cell carcinoma, other neoplastic diseases), or history of chemical or thermal ocular burn in either eye
Current or anticipated use of any preserved chronic topical ophthalmic medications in eyes or on eyelids in eyes with pterygium
Use (within 30 days prior to Screening) or anticipated use, in eyes with pterygium, of any topical ocular drugs that are anti-inflammatory
Use (within 90 days prior to Screening) or anticipated use, in eyes with pterygium
Artificial tears in eyes with pterygium used greater than 2 times per day
History or evidence of severe ocular trauma in the eye(s) with pterygium
Concurrent enrollment in an investigational drug or device study or participation in such a study within 30 days prior to Screening
Anticipated wearing of contact lenses in the eye with pterygium during the study
Anticipated pterygium surgery within a year
History of severe seasonal ocular allergy
Any condition or situation, which, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
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