Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

NCT04747808 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LL-BMT10001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Prostaglandin; Intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Adverse Event Rate

  Number of subjects with adverse events

  Day 7

Secondary Outcomes (2)

• Intraocular Pressure Elevation

  Day 7

• IOP Changes

  Days 1

Study Arms (1)

LL-BMT1

EXPERIMENTAL

Group 4 extended-wear contact lens printed with bimatoprost

Drug: LL-BMT1

Interventions

LL-BMT1 DRUG

Drug-printed contact lens in both eyes

LL-BMT1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MediPrint Ophthalmics, Inc.: lead

Study Sites (1)

Eye Research Foundatoin

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Chief Operating Officer
• Organization: MediPrint Ophthalmics, Inc.

clinical@mediprintlens.com

(858) 522-0815

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, non-comparative

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: January 8, 2021
• Primary Completion: February 16, 2021
• Study Completion: February 16, 2021
• Last Updated: June 8, 2022
• Results First Posted: May 10, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)