Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

MediPrint Ophthalmics, Inc.5 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Open Angle Glaucoma Ocular Hypertension

Interventions

LL-BMT1DRUG

Drug-printed contact lens in both eyes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Eye Research Foundatoin

Newport Beach, California, United States

Outcomes

Primary Outcomes

Adverse Event Rate

Number of subjects with adverse events

Time frame: Day 7

Secondary Outcomes

Intraocular Pressure Elevation

Number of subjects with IOP elevation \>= 5 mm Hg in study eye

Time frame: Day 7

IOP Changes

Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm

Time frame: Days 1

Data from ClinicalTrials.gov

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