Trial Outcomes & Findings for An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake (NCT NCT04280653)

Last Updated: 2020-12-08

Results Overview

The primary study endpoint will be the comparison of the tear lake volume at baseline with the tear lake volume at each follow-up visit. The tear lake will be evaluated using a slit lamp micrometer, the micrometer will be oriented vertically and centered on the lower lid margin at the middle of the lower lid. The tear lake will be measured using the slit lamp micrometer from the lid margin to the superior border of the lower tear lake and measured to 0.1 mm. The average mean percent change from baseline tear lake volume was compared to that at 7 days.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

7 days

Results posted on

2020-12-08

Participant Flow

Normal healthy volunteers were interviewed to determine if they were interested in participating in the study. Recruitment was in the ophthalmologist office by the study staff.

There was no wash out or run-in period in this study. There was only 1 arm in this study.

Participant milestones

Participant milestones
Measure	NDE L68 StableFit® Punctal Plug Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion NDE L68 StableFit® Punctal Plug: Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NDE L68 StableFit® Punctal Plug n=15 Participants Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion NDE L68 StableFit® Punctal Plug: Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion.
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	14 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
Region of Enrollment United States	15 participants n=5 Participants
Age, Customized 20-<25 years	1 Participants n=5 Participants
Age, Customized 25- <30 years	4 Participants n=5 Participants
Age, Customized 30-<35 years	4 Participants n=5 Participants
Age, Customized 45- <50 years	2 Participants n=5 Participants
Age, Customized 55- <60 years	2 Participants n=5 Participants
Age, Customized 60- <65 years	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Outcome measures
Measure	NDE L68 StableFit® Punctal Plug n=15 Participants Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion NDE L68 StableFit® Punctal Plug: Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion.
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days	129 mean percent change from baseline Interval 125.0 to 166.0

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	NDE L68 StableFit® Punctal Plug n=15 Participants Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion NDE L68 StableFit® Punctal Plug: Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion.
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days	143 mean percent change from baseline Interval 113.0 to 166.0

SECONDARY outcome

Timeframe: 28 days

Population: The subjects were interviewed at the final visit (28 days) by the Investigator and rated the acceptability of the punctal plug as Very acceptable/Acceptable/somewhat Acceptable/Unacceptable/extremely unaccable

Questionnaire

Outcome measures

Outcome measures
Measure	NDE L68 StableFit® Punctal Plug n=15 Participants Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion NDE L68 StableFit® Punctal Plug: Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion.
Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days Very Acceptable	7 Participants
Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days Acceptable	7 Participants
Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days Somewhat Acceptable	1 Participants
Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days Somewhat Unacceptable	0 Participants
Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days Extremely Unacceptable	0 Participants
Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days Unacceptable	0 Participants

Adverse Events

NDE L68 StableFit® Punctal Plug

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NDE L68 StableFit® Punctal Plug n=15 participants at risk Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion
Eye disorders Clinically significant slit-lamp findings	6.7% 1/15 • Number of events 1 • Adverse event data were collected over the period of the study, 28 days. To assess subject's qualifications for enrollment and safety of the punctal plug, the investigator evaluated: 1. Visit 1 Record any clinically significant Ocular Pain or Discomfort Record any clinically significant slit-lamp findings (lid, conjunctival, corneal) At the conclusion of the baseline visit, did the subject experience an adverse device event (ADE) 2. Follow-up Visits Record any clinically significant slit-lamp findings (lid, conjunctival, corneal) Record ADE since last visit

Additional Information

Deepank Utkhede

Mati Therapeutics Inc.

Phone: 778-991-3301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After final publication or not published within 12 months following the conclusion of the last of the multi-center sites, and only with written consent of, and review and comment by, the Sponsor, any publication/lecture manuscripts proposed by the Study Center or the Investigator which are to make public any findings, data or results of the Study or any ancillary study must be submitted to the Sponsor for its review, and comment at least ninety days prior to submission for publication.
Publication restrictions are in place

Restriction type: OTHER