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NCT04747808 Clinical Trial

Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

Ocular Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04747808
Other study ID # LL-BMT10001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 8, 2021
Est. completion date February 16, 2021

Study information
Verified date April 2022
Source MediPrint Ophthalmics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date February 16, 2021
Est. primary completion date February 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LL-BMT1
Drug-printed contact lens in both eyes

Locations
Country Name City State
United States Eye Research Foundatoin Newport Beach California

Sponsors (1)
Lead Sponsor Collaborator
MediPrint Ophthalmics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Event Rate Number of subjects with adverse events Day 7
Secondary Intraocular Pressure Elevation Number of subjects with IOP elevation >= 5 mm Hg in study eye Day 7
Secondary IOP Changes Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm Days 1
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