Study of LL-BMT1 in Patients With Elevated Intraocular Pressure
- Registration Number
- NCT04747808
- Lead Sponsor
- MediPrint Ophthalmics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LL-BMT1 LL-BMT1 Group 4 extended-wear contact lens printed with bimatoprost
- Primary Outcome Measures
Name Time Method Adverse Event Rate Day 7 Number of subjects with adverse events
- Secondary Outcome Measures
Name Time Method IOP Changes Days 1 Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm
Intraocular Pressure Elevation Day 7 Number of subjects with IOP elevation \>= 5 mm Hg in study eye
Trial Locations
- Locations (1)
Eye Research Foundatoin
🇺🇸Newport Beach, California, United States