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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LL-BMT1 | Experimental | Group 4 extended-wear contact lens printed with bimatoprost |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LL-BMT1 | Drug | Drug-printed contact lens in both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Rate | Number of subjects with adverse events | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure Elevation | Number of subjects with IOP elevation >= 5 mm Hg in study eye | Day 7 |
| IOP Changes | Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundatoin | Newport Beach | California | 92663 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | LL-BMT1 | Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LL-BMT1 | Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Event Rate | Number of subjects with adverse events | Posted | Count of Participants | Participants | Day 7 |
|
|
8 Days
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LL-BMT1 | Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular irritation | Eye disorders | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Operating Officer | MediPrint Ophthalmics, Inc. | (858) 522-0815 | clinical@mediprintlens.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2020 | Apr 15, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 11, 2021 | Apr 15, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Open-label, non-comparative
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| Days 1 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Intraocular pressure (study eye) | Mean | Standard Deviation | mm Hg |
|
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| Secondary | Intraocular Pressure Elevation | Number of subjects with IOP elevation >= 5 mm Hg in study eye | Posted | Count of Participants | Participants | Day 7 |
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| Secondary | IOP Changes | Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm | Posted | Mean | Standard Deviation | mmHg | Days 1 |
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| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
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