PterygiumPhase 3NCT05456425
A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium
A Phase 3 study testing CBT-001 in people with Pterygium, run by Cloudbreak Therapeutics, LLC at 44 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- CBT-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 44 sitesin 5 countries
- Study dates
- 30 Jun 2022to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pterygium with conjunctival hyperemia
Who cannot join
- Pterygium removal within the last 6 months
Trial locations and contacts
44 sites in 5 countries.
44 sites in 5 countries
United States20 sites
West Coast Eye Institute
Bakersfield, California, 93311
Advanced Research; LLC
Deerfield Beach, Florida, 33064
Bruce A. Segal, MD
Delray Beach, Florida, 33484
Trinity Research Group
Dothan, Alabama, 36301
Emerson Clinical Research Institute, LLC
Falls Church, Virginia, 22046
Global Research Mangement
Glendale, California, 91204
Inland Eye Specialists
Hemet, California, 92545
Center for Sight
Henderson, Nevada, 89052
Baylor College of Medicine
Houston, Texas, 77030
The Eye Care Institute
Louisville, Kentucky, 40206
DCT-Shah Research, LLC dba Discovery Clinical Trials
McAllen, Texas, 78572
Eye Research Foundation
Newport Beach, California, 92663
Shultz Chang Vision
Northridge, California, 91325
North Bay Eye Associates INC
Petaluma, California, 94954
Clinical Trials of Texas
San Antonio, Texas, 78229
R and R Eye Research
San Antonio, Texas, 78229
Santa Barbara Eye Care
Santa Barbara, California, 93105
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Horizon Eye Specialists & LASIK Center
Sun City, Arizona, 83531
International Research Center
Tampa, Florida, 33603
China10 sites
Beijing Tongren Hospital; CMU
Beijing, 100730
West China Hospital of Sichuan University
Chengdu, 610041
Hainan Provincial Eye Hospital
Haikou, 570311
1st Affiliated Hospital of University of South China
Hengyang, 421001
The Second People's Hospital of Yunnan Province
Kunming, 650021
The First Affiliated Hospital of NC University
Nanchang, 330006
Eye Hospital of Shandong First Medical University
Qingdao, 250021
Eye Hospital of Wenzhou Medical University
Wenzhou, 325027
Union Hospital Tongji Medical College
Wuhan, 430022
Xiamen Eye Center of Xiamen University
Xiamen, 361004
India6 sites
Netralaya Super Specialty Eye Hospital
Ahmedabad, Gujarat, 380006
Narayana Nethralaya
Bangalore, Karnataka, 560010
L V Prasad Eye Institute
Bhubaneswar, Odisha, 751024
SP Medical College and AG of Hospitals
Bikaner, Rajasthan, 334001
Advanced Eye Centre PGIMER
Chandigarh, Chandigarh, 160012
Icare Eye Hospital
Noida, Uttar Pradesh, 201301
Australia5 sites
Eyeclinic Albury Wodonga
Albury, New South Wales, 2640
Bendigo Eye Clinic
Bendigo, Victoria, 3021
The Centre for Eye Research Australia
East Melbourne, Melbourne, 3002
Sunshine Eye Surgeons
St Albans, Victoria, 3021
Sydney Eye Hospital
Sydney, New South Wales, 2000
New Zealand3 sites
Auckland Eye
Auckland, 1050
Eye Institute
Auckland, 1050
Southern Eye Specialists
Christchurch, 8013
About this study
Official 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
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.
Read the detailed description
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 dosed twice daily maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-001Drug
CBT-001 eye drop
VehicleDrug
Formulation without drug
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Emulsion eye drop without drug Receives: Drug: Vehicle |
| CBT-001 Low Dose | Experimental | CBT-001 eye drop Receives: Drug: CBT-001 |
| CBT-001 High Dose | Experimental | CBT-001 eye drop Receives: Drug: CBT-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
conjunctival hyperemia
Mean difference of conjunctival hyperemia grade change from baseline.
Measured: 3 month
pterygium length
Mean difference of pterygium lesion length change from baseline.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start30 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Double-Masked, Randomized, Vehicle-Controlled Parallel Comparison with dosing twice-daily in eye(s) with pterygium
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cloudbreak Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456425
- Sponsor's protocol ID
- CBT-CS301
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05456425
- Acronym / sponsor ID
- CBT-CS301
- Conditions
- Pterygium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Cloudbreak Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 dosed twice daily maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Multicenter, Double-Masked, Randomized, Vehicle-Controlled Parallel Comparison with dosing twice-daily in eye(s) with pterygium
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: VehicleEmulsion eye drop without drug |
| CBT-001 Low Dose | Experimental | Drug: CBT-001CBT-001 eye drop |
| CBT-001 High Dose | Experimental | Drug: CBT-001CBT-001 eye drop |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pterygium with conjunctival hyperemia
Key exclusion criteria (1 listed)
- Pterygium removal within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-001CBT-001 eye drop | Drug | CBT-001 High Dose, CBT-001 Low Dose |
| VehicleFormulation without drug | Drug | Vehicle |
Primary outcome
conjunctival hyperemia
Time frame: 3 month
Mean difference of conjunctival hyperemia grade change from baseline.
pterygium length
Time frame: 12 month
Mean difference of pterygium lesion length change from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Pterygium
Not yet recruiting
Video-Assisted Patient Education and Eye Fixation Training in Pterygium Surgery
Pterygium, Preoperative Anxiety
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruitingPhase 1
Air-Dried Human Amniotic Membrane Terminally Sterilized by Gamma Irradiation for Multidisciplinary Clinical Application
Diabetic Foot Ulcer (DFU), Ocular Disorder
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
Recruiting
Conjunctival Transpositional Surgery for Primary Pterygium
Pterygium of the Conjunctiva and Cornea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CBT-001 in people with Pterygium, run by Cloudbreak Therapeutics, LLC at 44 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, China, India, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conjunctival hyperemia (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.