Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Keywords
Glaucoma, Prostaglandin, Intraocular pressure
Brief 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.
Interventions
DRUGLL-BMT1
Drug-printed contact lens in both eyes
Sponsors
MediPrint Ophthalmics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, non-comparative
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Rate | Day 7 | Number of subjects with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure Elevation | Day 7 | Number of subjects with IOP elevation \>= 5 mm Hg in study eye |
| IOP Changes | Days 1 | Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LL-BMT1 Group 4 extended-wear contact lens printed with bimatoprost
LL-BMT1: Drug-printed contact lens in both eyes | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | LL-BMT1 |
|---|---|
| Age, Continuous | 77.4 years STANDARD_DEVIATION 4.4 |
| Intraocular pressure (study eye) | 24.7 mm Hg STANDARD_DEVIATION 3.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Adverse Event Rate
Number of subjects with adverse events
Time frame: Day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LL-BMT1 | Adverse Event Rate | 1 Participants |
Secondary
Intraocular Pressure Elevation
Number of subjects with IOP elevation \>= 5 mm Hg in study eye
Time frame: Day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LL-BMT1 | Intraocular Pressure Elevation | 0 Participants |
Secondary
IOP Changes
Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm
Time frame: Days 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LL-BMT1 | IOP Changes | -2.9 mmHg | Standard Deviation 0.7 |