Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

MediPrint Ophthalmics

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: LL-BMT1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04747808

LL-BMT10001

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

LL-BMT1

Experimental group

Description:

Group 4 extended-wear contact lens printed with bimatoprost

Treatment:

Drug: LL-BMT1