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Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LL-BMT1
Sponsored by
MediPrint Ophthalmics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Glaucoma, Prostaglandin, Intraocular pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Eye Research Foundatoin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LL-BMT1

Arm Description

Group 4 extended-wear contact lens printed with bimatoprost

Outcomes

Primary Outcome Measures

Adverse Event Rate
Number of subjects with adverse events

Secondary Outcome Measures

Intraocular Pressure Elevation
Number of subjects with IOP elevation >= 5 mm Hg in study eye
IOP Changes
Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm

Full Information

First Posted
February 5, 2021
Last Updated
June 7, 2022
Sponsor
MediPrint Ophthalmics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04747808
Brief Title
Study of LL-BMT1 in Patients With Elevated Intraocular Pressure
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
February 16, 2021 (Actual)
Study Completion Date
February 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MediPrint Ophthalmics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension
Keywords
Glaucoma, Prostaglandin, Intraocular pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label, non-comparative
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LL-BMT1
Arm Type
Experimental
Arm Description
Group 4 extended-wear contact lens printed with bimatoprost
Intervention Type
Drug
Intervention Name(s)
LL-BMT1
Intervention Description
Drug-printed contact lens in both eyes
Primary Outcome Measure Information:
Title
Adverse Event Rate
Description
Number of subjects with adverse events
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Intraocular Pressure Elevation
Description
Number of subjects with IOP elevation >= 5 mm Hg in study eye
Time Frame
Day 7
Title
IOP Changes
Description
Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm
Time Frame
Days 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Eye Research Foundatoin
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

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