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Clinical Trials
Cloudbreak
A Multicenter, Double-Masked, Randomized, Vehicle-Controlled 12-Month (with a 12-month, Double-Masked Extension) Parallel Comparison of the Safety and Efficacy of 0.1% and 0.2% CBT-001 versus Vehicle, Dosed Twice-Daily, in Patients with Pterygium.
Overview
This research project will investigate a new treatment for pterygium called CBT-001. A pterygium is a wedge-shaped thickening of the outer coating of the eye that extends onto the cornea that can become red and irritated.
CBT-001 ophthalmic emulsion is the investigational study drug that is being tested in this study.
The active medicine in the study drug is a multikinase inhibitor (a medicine that can stop a number of proteins involved in disorders such as pterygium).
CBT-001 has not been approved for use by the regulatory authorities of Australia (Therapeutic Goods Administration) nor by that of the USA (Food and Drug Administration), and as such it is an experimental treatment.
The main purpose of this study is to look at how safe the study drug is and whether it works to treat pterygium.
During the study, one drop of the study drug will be applied to the eye(s) with pterygium twice daily by the participant for 24 months. Participants will be randomly assigned to receive either the study drug or placebo. There is a 3 out of 4 chance of receiving the study drug, versus placebo. For further information about this study please contact the Cerulea on (03)0638 5300 or email info@ceruleaclinicaltrials.org.au
- Principal Investigator
Professor Mark Daniell
This research project will investigate a new treatment for pterygium called CBT-001. A pterygium is a wedge-shaped thickening of the outer coating of the eye that extends onto the cornea that can become red and irritated.
CBT-001 ophthalmic emulsion is the investigational study drug that is being tested in this study.
The active medicine in the study drug is a multikinase inhibitor (a medicine that can stop a number of proteins involved in disorders such as pterygium).
CBT-001 has not been approved for use by the regulatory authorities of Australia (Therapeutic Goods Administration) nor by that of the USA (Food and Drug Administration), and as such it is an experimental treatment.
The main purpose of this study is to look at how safe the study drug is and whether it works to treat pterygium.
During the study, one drop of the study drug will be applied to the eye(s) with pterygium twice daily by the participant for 24 months. Participants will be randomly assigned to receive either the study drug or placebo. There is a 3 out of 4 chance of receiving the study drug, versus placebo. For further information about this study please contact the Cerulea on (03)0638 5300 or email info@ceruleaclinicaltrials.org.au
- Principal Investigator
Learn more
View this study on ClinicalTrials.gov
See the ClinicalTrials.gov database listing for more detailed information about this study.