Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

• Sponsor: MediPrint Ophthalmics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04747808
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 3.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma; Ocular Hypertension	Drug: LL-BMT1	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open-label, non-comparativeOpen-label, non-comparative
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 8, 2021
• Actual Primary Completion Date: Feb 16, 2021
• Actual Study Completion Date: Feb 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LL-BMT1 Group 4 extended-wear contact lens printed with bimatoprost	Drug: LL-BMT1; Drug-printed contact lens in both eyes

Outcome Measures

Primary Outcome Measures

1. Adverse Event Rate [Day 7]

   Number of subjects with adverse events

Secondary Outcome Measures

1. Intraocular Pressure Elevation [Day 7]

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

2. IOP Changes [Days 1]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Research Foundatoin	Newport Beach	California	United States	92663

Sponsors and Collaborators

• MediPrint Ophthalmics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Dec 21, 2020
• Statistical Analysis Plan - Feb 11, 2021

More Information

Publications

None provided.

• Responsible Party: MediPrint Ophthalmics, Inc.
• ClinicalTrials.gov Identifier: NCT04747808
• Other Study ID Numbers: LL-BMT10001
• First Posted: Feb 10, 2021
• Last Update Posted: Jun 8, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by MediPrint Ophthalmics, Inc.: Glaucoma; Prostaglandin; Intraocular pressure
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension

Study Results

Participant Flow

Arm/Group Title	LL-BMT1
Arm/Group Description	Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	LL-BMT1
Arm/Group Description	Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
Overall Participants	5
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	77.4 (4.4)
Sex: Female, Male (Count of Participants)
Female	4 80%
Male	1 20%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	5 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Intraocular pressure (study eye) (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	24.7 (3.3)

Outcome Measures

1. Primary Outcome

Title	Adverse Event Rate
Description	Number of subjects with adverse events
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LL-BMT1
Arm/Group Description	Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
Measure Participants	5
Count of Participants [Participants]	1 20%

2. Secondary Outcome

Title	Intraocular Pressure Elevation
Description	Number of subjects with IOP elevation >= 5 mm Hg in study eye
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LL-BMT1
Arm/Group Description	Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
Measure Participants	5
Count of Participants [Participants]	0 0%

3. Secondary Outcome

Title	IOP Changes
Description	Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm
Time Frame	Days 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LL-BMT1
Arm/Group Description	Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
Measure Participants	5
Mean (Standard Deviation) [mmHg]	-2.9 (0.7)

Adverse Events

Time Frame	8 Days
Adverse Event Reporting Description	Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Arm/Group Title	LL-BMT1
Arm/Group Description	Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
All Cause Mortality
	LL-BMT1
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	LL-BMT1
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	LL-BMT1
	Affected / at Risk (%)	# Events
Total	1/5 (20%)
Eye disorders
Ocular irritation	1/5 (20%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.