PingueculaPhase 2NCT04884256
Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula
A Phase 2 study testing CBT-004 in people with Pinguecula, run by Cloudbreak Therapeutics, LLC at 1 site in United States.
Trial summary
STUDY DESIGN: Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. Duration of Treatment: 4 weeks of study treatment with 4 weeks follow-up observations. Control: Vehicle for CBT-004 (hereafter referred to as Vehicle). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pinguecula
- What is being tested?
- CBT-004
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2023to 30 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pinguecula with a vascularity grade ≥ 3 on a 5-point (0-4) scale.
- Ocular bothersome questionnaire score ≥ 2 on a 5-point (0-4) scale.
- ≥ 18 years of age.
- Able to provide written informed consent and comply with study assessments for the full duration of the study.
Who cannot join
- Uncontrolled systemic disease, in the opinion of the investigator.
- Active ocular disease other than pinguecula that may confound the study data, including but not limited to severe dry eye disease, pterygium, uncontrolled blepharitis, anterior membrane dystrophy, Salzmann's, glaucoma, or active ocular infection.
- History of ocular herpes disease, iritis/uveitis, in either eye.
- Any ocular surgical procedure within the last 3 months or anticipated ocular surgery during the study, in either eye.
- Anticipated wearing of contact lenses during any portion of the study. Patients, who wear soft contact lenses should discontinue wearing them at least 7 days prior to Day 1 visit. Patients wearing rigid gas permeable or hard contact lenses should discontinue wearing them at least 3 weeks prior to Day 1 visit.
- Female patients who are pregnant, nursing, or planning a pregnancy during the study.
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- Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to entry into this study.
- History of myocardial infarction or stroke.
- Any condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
- Known allergy or sensitivity to the study medication(s) or its components.
- Current or anticipated use of topical ophthalmic medications in the study eye. Patients must have discontinued use of ophthalmic medications in the study eye for at least 2 weeks (4 weeks for Restasis® or Xiidra®) prior to Day 1 visit. Artificial tears are allowed in the study eye until 7 days prior to Visit 1 and should not be used during the treatment phase of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Research Management
Glendale, California, 91204
About this study
Official title: A Phase 2 Multicenter, Randomized, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of CBT-004 Ophthalmic Emulsion in Patients With Vascularized Pinguecula
STUDY DESIGN:
Structure:
Read more
Multicenter, randomized, double-masked, vehicle-controlled, parallel-group study.
Duration of Treatment:
4 weeks of study treatment with 4 weeks follow-up observations.
Control:
Vehicle for CBT-004 (hereafter referred to as Vehicle).
Masking:
Subjects, Investigators, Study Monitors and the Independent Image Reading Center are all masked to the study medications.
Dosage/Dose regimen:
One drop of the assigned study medication will be administered in the study eye TID for 4 weeks. The study eye is defined as the qualified eye (i.e., the eye meeting the inclusion criterion for vascularized pinguecula). If both eyes are qualified, then the eye with the more severe vascularity grade at Visit 1 will be the study eye.
- Conditions
- Pinguecula
- Being tested
- CBT-004
- Medical subject headings
- Pinguecula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-004Drug
Dose response study
| Study group | Role | What they receive |
|---|---|---|
| CBT-004 | Placebo comparator | Not described Receives: Drug: CBT-004 |
| 0.05% CBT-004 | Experimental | Not described Receives: Drug: CBT-004 |
| 0.075% CBT-004 | Experimental | Not described Receives: Drug: CBT-004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in conjunctival hyperemia grade at Day 28 (Week 4).
Measured: 1 month
Secondary outcomes (1)
Change from Baseline conjunctival hyperemia digital image grade at Days 7 (Week 1) and 56 (Week 8).
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start21 Dec 2023
- Primary completion17 Apr 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PingueculaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 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
- NCT04884256
- Sponsor's protocol ID
- CBT-CS103
- Status last verified
- Feb 2025
- First submitted
- 5 May 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of CBT-004 Ophthalmic Emulsion in Patients With Vascularized Pinguecula
- ClinicalTrials.gov ID
- NCT04884256
- Acronym / sponsor ID
- CBT-CS103
- Conditions
- Pinguecula
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Cloudbreak Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 12 May 2021 (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.
STUDY DESIGN:
Structure:
Multicenter, randomized, double-masked, vehicle-controlled, parallel-group study.
Duration of Treatment:
4 weeks of study treatment with 4 weeks follow-up observations.
Control:
Vehicle for CBT-004 (hereafter referred to as Vehicle).
Masking:
Subjects, Investigators, Study Monitors and the Independent Image Reading Center are all masked to the study medications.
Dosage/Dose regimen:
One drop of the assigned study medication will be administered in the study eye TID for 4 weeks. The study eye is defined as the qualified eye (i.e., the eye meeting the inclusion criterion for vascularized pinguecula). If both eyes are qualified, then the eye with the more severe vascularity grade at Visit 1 will be the study eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-004 | Placebo comparator | Drug: CBT-004 |
| 0.05% CBT-004 | Experimental | Drug: CBT-004 |
| 0.075% CBT-004 | Experimental | Drug: CBT-004 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pinguecula with a vascularity grade ≥ 3 on a 5-point (0-4) scale.
- Ocular bothersome questionnaire score ≥ 2 on a 5-point (0-4) scale.
- ≥ 18 years of age.
- Able to provide written informed consent and comply with study assessments for the full duration of the study.
Key exclusion criteria (11 listed)
- Uncontrolled systemic disease, in the opinion of the investigator.
- Active ocular disease other than pinguecula that may confound the study data, including but not limited to severe dry eye disease, pterygium, uncontrolled blepharitis, anterior membrane dystrophy, Salzmann's, glaucoma, or active ocular infection.
- History of ocular herpes disease, iritis/uveitis, in either eye.
- Any ocular surgical procedure within the last 3 months or anticipated ocular surgery during the study, in either eye.
- Anticipated wearing of contact lenses during any portion of the study. Patients, who wear soft contact lenses should discontinue wearing them at least 7 days prior to Day 1 visit. Patients wearing rigid gas permeable or hard contact lenses should discontinue wearing them at least 3 weeks prior to Day 1 visit.
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-004Dose response study | Drug | 0.05% CBT-004, 0.075% CBT-004, CBT-004 |
Primary outcome
Change from Baseline in conjunctival hyperemia grade at Day 28 (Week 4).
Time frame: 1 month
1 secondary outcome
Change from Baseline conjunctival hyperemia digital image grade at Days 7 (Week 1) and 56 (Week 8).
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBT-004 in people with Pinguecula, run by Cloudbreak Therapeutics, LLC at 1 site in United States.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in conjunctival hyperemia grade at Day 28 (Week 4). (time frame: 1 month). 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 5 Jun 2025.