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OpenTrials
Completed

NCT Number: NCT04747808

Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

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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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eye Research Foundatoin

Newport Beach, California, 92663, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LL-BMT1

Drug

Drug-printed contact lens in both eyes

Primary outcomes

  1. Adverse Event Rate

    Time frame: Day 7

    Number of subjects with adverse events

Secondary outcomes

  1. Intraocular Pressure Elevation

    Time frame: Day 7

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

  2. IOP Changes

    Time frame: Days 1

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

Sponsors and collaborators

Lead sponsor

MediPrint Ophthalmics, Inc.

Industry

Registry information

Official study title

A Phase 2a Study of Safety, Tolerability, and Efficacy of Drug-Delivering Contact Lens LL-BMT1 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2021
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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