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

Study Overview
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Brief Summary
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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.

Detailed Description
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Clinical Hypotheses: 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. Preventing pterygium progression, by demonstrating a statistically significant and clinically relevant improvement on drug vs vehicle mean difference in the change in pterygium length from baseline. CBT-001 emulsion maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.

Official Title
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Multicenter, Double-Masked, Randomized, Vehicle-Controlled 12-Month Parallel Comparison of the Safety and Efficacy of 0.1% and 0.2% CBT-001 Versus Vehicle, Dosed Twice-Daily, in Patients With Pterygium

Conditions
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Pterygium

Intervention / Treatment
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* Drug: CBT-001
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, Double-Masked, Randomized, Vehicle-Controlled Parallel Comparison with dosing twice-daily in eye(s) with pterygium
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Emulsion eye drop without drug | Drug: Vehicle<br>* Formulation without drug<br>|
| Experimental: 0.1% CBT-001<br>0.1% CBT-001 emulsion eye drop | Drug: CBT-001<br>* A multi-kinase inhibitor<br>|
| Experimental: 0.2% CBT-001<br>0.2% CBT-001 emulsion eye drop | Drug: CBT-001<br>* A multi-kinase inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conjunctival hyperemia | Mean difference of conjunctival hyperemia grade change from baseline. | 3 month | 
| pterygium length | Mean difference of pterygium lesion length change from baseline. | 12 month |