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A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium
The objective is to evaluate the safety and efficacy of low dose and high dose CBT-001 eye drop dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.
Study details:
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. * 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. 2.
CBT-001 dosed twice daily maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 12 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-06-30
Primary completion: 2025-12-31
Study completion finish: 2026-12-31
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05456425
Intervention or treatment
DRUG: CBT-001
DRUG: Vehicle
Conditions
- • Pterygium
Find a site
Closest Location:
The Centre for Eye Research Australia
Research sites nearby
Select from list below to view details:
The Centre for Eye Research Australia
East Melbourne, Melbourne, Australia
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia
Sunshine Eye Surgeons
St Albans, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
PLACEBO_COMPARATOR: Vehicle
| DRUG: Vehicle
|
EXPERIMENTAL: CBT-001 Low Dose
| DRUG: CBT-001
|
EXPERIMENTAL: CBT-001 High Dose
| DRUG: CBT-001
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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 |
Secondary outcome
Frequently Asked Questions
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