Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-08

Study Completion Date

2021-02-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label, non-comparative

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LL-BMT1

Group 4 extended-wear contact lens printed with bimatoprost

Group Type EXPERIMENTAL

LL-BMT1

Intervention Type DRUG

Drug-printed contact lens in both eyes

Interventions

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LL-BMT1

Drug-printed contact lens in both eyes

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No