Primary Open Angle GlaucomaPhase 2NCT04747808
Study of LL-BMT1 in Patients With Elevated Intraocular Pressure
A Phase 2 study testing LL-BMT1 in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by MediPrint Ophthalmics, Inc. at 1 site in United States.
Trial summary
This is an open-label, Phase 2a clinical study of LL-BMT1 in patients with primary open-angle glaucoma and ocular hypertension. Study subjects will be treated for 7 days with a single dose of LL-BMT1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- LL-BMT1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2021to 16 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age at the Screening Visit
- Diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes
- At least one eye (called the study eye) must have an untreated intraocular pressure between 22 mmHg and 34 mmHg (inclusive) as measured at 9 am during the Baseline Visit.
- Best corrected visual acuity of Early Treatment Diabetic Retinopathy Study of 50 letters or better
Who cannot join
- Glaucoma or optic neuropathy due to anything other than above noted reasons Cup-to-disc ratio of >0.8 in either eye
- Corneal thickness <480 or >620 μm
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Research Foundatoin
Newport Beach, California, 92663
About this study
Official title: A Phase 2a Study of Safety, Tolerability, and Efficacy of Drug-Delivering Contact Lens LL-BMT1 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
This is an open-label, Phase 2a clinical study of LL-BMT1 in patients with primary open-angle glaucoma and ocular hypertension. Study subjects will be treated for 7 days with a single dose of LL-BMT1.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- LL-BMT1
- Keywords
- Glaucoma, Prostaglandin, Intraocular pressure
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LL-BMT1Drug
Drug-printed contact lens in both eyes
| Study group | Role | What they receive |
|---|---|---|
| LL-BMT1 | Experimental | Group 4 extended-wear contact lens printed with bimatoprost Receives: Drug: LL-BMT1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Rate
Number of subjects with adverse events
Measured: Day 7
Secondary outcomes (2)
Intraocular Pressure Elevation
Number of subjects with IOP elevation >= 5 mm Hg in study eye
Measured: Day 7
IOP Changes
Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm
Measured: Days 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start8 Jan 2021
- Primary completion16 Feb 2021
- Study completion16 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Open Angle GlaucomaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, non-comparative
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediPrint Ophthalmics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747808
- Sponsor's protocol ID
- LL-BMT10001
- Status last verified
- Apr 2022
- First submitted
- 5 Feb 2021
- Last updated
- 8 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study of Safety, Tolerability, and Efficacy of Drug-Delivering Contact Lens LL-BMT1 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT04747808
- Acronym / sponsor ID
- LL-BMT10001
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Prostaglandin, Intraocular pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- MediPrint Ophthalmics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, Phase 2a clinical study of LL-BMT1 in patients with primary open-angle glaucoma and ocular hypertension. Study subjects will be treated for 7 days with a single dose of LL-BMT1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, non-comparative
| Arm | Type | Receives |
|---|---|---|
| LL-BMT1 | Experimental | Drug: LL-BMT1Group 4 extended-wear contact lens printed with bimatoprost |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, at least 18 years of age at the Screening Visit
- Diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes
- At least one eye (called the study eye) must have an untreated intraocular pressure between 22 mmHg and 34 mmHg (inclusive) as measured at 9 am during the Baseline Visit.
- Best corrected visual acuity of Early Treatment Diabetic Retinopathy Study of 50 letters or better
Key exclusion criteria (2 listed)
- Glaucoma or optic neuropathy due to anything other than above noted reasons Cup-to-disc ratio of >0.8 in either eye
- Corneal thickness <480 or >620 μm
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 |
|---|---|---|
| LL-BMT1Drug-printed contact lens in both eyes | Drug | LL-BMT1 |
Primary outcome
Adverse Event Rate
Time frame: Day 7
Number of subjects with adverse events
2 secondary outcomes
Intraocular Pressure Elevation
Time frame: Day 7
IOP Changes
Time frame: Days 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 LL-BMT1 in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by MediPrint Ophthalmics, Inc. 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 2 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 8 Jun 2022. 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. 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?
Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Event Rate (time frame: Day 7). 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 8 Jun 2022.