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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05456425




Registration number
NCT05456425
Ethics application status
Date submitted
9/07/2022
Date registered
13/07/2022
Date last updated
2/04/2024

Titles & IDs
Public title
A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium
Scientific title
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
Secondary ID [1] 0 0
CBT-CS301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pterygium 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CBT-001
Treatment: Drugs - Vehicle

Placebo Comparator: Vehicle - Emulsion eye drop without drug

Experimental: CBT-001 Low Dose - CBT-001 eye drop

Experimental: CBT-001 High Dose - CBT-001 eye drop


Treatment: Drugs: CBT-001
CBT-001 eye drop

Treatment: Drugs: Vehicle
Formulation without drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
conjunctival hyperemia
Timepoint [1] 0 0
3 month
Primary outcome [2] 0 0
pterygium length
Timepoint [2] 0 0
12 month

Eligibility
Key inclusion criteria
Pterygium with conjunctival hyperemia
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pterygium removal within the last 6 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
MelbourneNSW,VIC
Recruitment hospital [1] 0 0
The Centre for Eye Research Australia - East Melbourne
Recruitment hospital [2] 0 0
Eyeclinic Albury Wodonga - Albury
Recruitment hospital [3] 0 0
Sunshine Eye Surgeons - St Albans
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
2640 - Albury
Recruitment postcode(s) [3] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
South Dakota
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Chengdu
Country [12] 0 0
China
State/province [12] 0 0
Haikou
Country [13] 0 0
China
State/province [13] 0 0
Hengyang
Country [14] 0 0
China
State/province [14] 0 0
Kunming
Country [15] 0 0
China
State/province [15] 0 0
Nanchang
Country [16] 0 0
China
State/province [16] 0 0
Qingdao
Country [17] 0 0
China
State/province [17] 0 0
Wenzhou
Country [18] 0 0
China
State/province [18] 0 0
Wuhan
Country [19] 0 0
China
State/province [19] 0 0
Xiamen
Country [20] 0 0
India
State/province [20] 0 0
Gujarat
Country [21] 0 0
India
State/province [21] 0 0
Karnataka
Country [22] 0 0
India
State/province [22] 0 0
Maharashtra
Country [23] 0 0
India
State/province [23] 0 0
Odisha
Country [24] 0 0
India
State/province [24] 0 0
Rajasthan
Country [25] 0 0
India
State/province [25] 0 0
Uttar Pradesh
Country [26] 0 0
India
State/province [26] 0 0
Chandigarh
Country [27] 0 0
New Zealand
State/province [27] 0 0
Auckland
Country [28] 0 0
New Zealand
State/province [28] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cloudbreak Therapeutics, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05456425
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Abu Abraham, MD
Address 0 0
Country 0 0
Phone 0 0
949-234-7147
Fax 0 0
Email 0 0
CBT-CS301Study@cloudbreakpharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05456425