Trial Outcomes & Findings for Study of LL-BMT1 in Patients With Elevated Intraocular Pressure (NCT NCT04747808)

NCT ID: NCT04747808

Last Updated: 2022-06-08

Results Overview

Number of subjects with adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Day 7
• Results posted on: 2022-06-08

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

Baseline characteristics by cohort

Measure	LL-BMT1 n=5 Participants Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
Age, Continuous	77.4 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Intraocular pressure (study eye)	24.7 mm Hg STANDARD_DEVIATION 3.3 • n=5 Participants

PRIMARY outcome

Timeframe: Day 7

Number of subjects with adverse events

Outcome measures

Measure	LL-BMT1 n=5 Participants Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
Adverse Event Rate	1 Participants

SECONDARY outcome

Timeframe: Day 7

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

Outcome measures

Measure	LL-BMT1 n=5 Participants Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
Intraocular Pressure Elevation	0 Participants

SECONDARY outcome

Timeframe: Days 1

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

Outcome measures

Measure	LL-BMT1 n=5 Participants Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
IOP Changes	-2.9 mmHg Standard Deviation 0.7

Adverse Events

LL-BMT1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LL-BMT1 n=5 participants at risk Group 4 extended-wear contact lens printed with bimatoprost LL-BMT1: Drug-printed contact lens in both eyes
Eye disorders Ocular irritation	20.0% 1/5 • Number of events 1 • 8 Days 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.

Additional Information

Chief Operating Officer

MediPrint Ophthalmics, Inc.

Phone: (858) 522-0815

Email: clinical@mediprintlens.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place