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CBT-001 Eye Drops for Pterygium
Phase 3
Recruiting
Led By Bruce A Segal, ND
Research Sponsored by Cloudbreak Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
Study Summary
This trial is testing a new eye drops medication to see if it is safe and effective in reducing redness and preventing growth of a type of noncancerous growth on the eye.
Who is the study for?
This trial is for individuals at least 12 years old with pterygium and good general health. They must have a visual acuity of 20/200 or better in one eye, agree to use contraception if applicable, and not be pregnant or nursing. Excluded are those with uncontrolled diseases like cancer, active ocular infections, significant corneal abnormalities unrelated to pterygium, recent eye surgeries (except for pterygium excision), severe seasonal ocular allergies, history of ocular herpes or trauma.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of CBT-001 emulsion at two different concentrations (0.1% and 0.2%) against a placebo vehicle. Participants will apply the treatment twice daily for two years to see if it reduces redness and prevents the growth of their pterygium.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants may experience reactions related to eye treatments such as irritation, discomfort, redness or allergic responses due to sensitivity towards components in CBT-001.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
conjunctival hyperemia
pterygium length
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: CBT-001 Low DoseExperimental Treatment1 Intervention
CBT-001 eye drop
Group II: CBT-001 High DoseExperimental Treatment1 Intervention
CBT-001 eye drop
Group III: VehiclePlacebo Group1 Intervention
Emulsion eye drop without drug
Find a Location
Who is running the clinical trial?
Cloudbreak Therapeutics, LLCLead Sponsor
5 Previous Clinical Trials
416 Total Patients Enrolled
1 Trials studying Pterygium
75 Patients Enrolled for Pterygium
Bruce A Segal, NDPrincipal InvestigatorBruce A. Segal, MD
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any eye diseases like macular degeneration.I have had herpes in my eye before.I have a disease that is not under control and am receiving treatment for it.I am expected to have surgery for pterygium within a year.I, or my legal guardian, have given written consent to participate.I currently have an eye infection or pink eye.My eyes have significant issues not related to pterygium or its surgery.I use or plan to use eye drops regularly for an eye condition.I have used artificial tears more than twice a day for my eye condition in the last 3 months.I have not had any eye surgery, except for pterygium removal, in the last 3 months.I have had a severe eye injury in the past.I have had eye conditions like pseudo-pterygium, corneal disease, eye cancer, or burns.I am 12 years old or older.I agree to use birth control during the study.I am not pregnant, nursing, planning to become pregnant, or if of childbearing potential, I am using reliable contraception.I have used or plan to use anti-inflammatory eye drops for pterygium within the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: CBT-001 Low Dose
- Group 2: CBT-001 High Dose
- Group 3: Vehicle
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there available positions for participants in this research?
"The latest information on clinicaltrials.gov suggests that this trial is still searching for participants. The details of the trial were first posted on June 30th, 2020 and were updated as recently as July 18th, 2020."
Answered by AI
Has CBT-001 received government approval for public consumption?
"CBT-001 has received a safety score of 3 from our analysts at Power. This is because Phase 3 trials have yielded some efficacy data in addition to multiple rounds of safety data."
Answered by AI
How many people have signed up to test this new medical treatment?
"The information available on clinicaltrials.gov verifies that this study is actively recruiting patients. This trial was first posted on June 30th, 2022 and was updated on July 18th, 2022. 1 location is looking for 600 participants in total."
Answered by AI
Who else is applying?
What site did they apply to?
Walman Eye Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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