Phase 2 N=5 Treatment

Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

Primary Open Angle Glaucoma · Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT04747808 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Adverse Event Rate — 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LL-BMT1 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MediPrint Ophthalmics, Inc.
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Adverse Event Rate	1	—
SECONDARY Intraocular Pressure Elevation	—	—
SECONDARY IOP Changes	-2.9	—

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.

Eligibility Criteria

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 620 μm

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04747808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.