An interventional study of NDE L68 StableFit® Punctal Plug in Dry Eye Syndromes, sponsored by Mati Therapeutics Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by Mati Therapeutics Inc. · Not applicable, Interventional, and Treatment
To evaluate the effect of the NDE L68 StableFit® punctal plug on the tear lake.
This is a Non-Significant Risk (NSR) medical device, multi-center, open-label clinical study. 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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Mati Therapeutics Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: 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.
Also known as: L-shaped Punctal Plug
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days
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.
Time frame: 7 days
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days
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 28 days.
Time frame: 28 days
Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days
Questionnaire
Time frame: 28 days
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.
| Milestone | NDE L68 StableFit® Punctal Plug |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
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.
| mean percent change from baseline | NDE L68 StableFit® Punctal Plug |
|---|---|
| Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days | 129 (125 to 166) |
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 28 days.
| mean percent change from baseline | NDE L68 StableFit® Punctal Plug |
|---|---|
| Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days | 143 (113 to 166) |
Questionnaire
| Participants | NDE L68 StableFit® Punctal Plug |
|---|---|
| Very Acceptable | 7 |
| Acceptable | 7 |
| Somewhat Acceptable | 1 |
| Somewhat Unacceptable | 0 |
| Unacceptable | 0 |
| Extremely Unacceptable | 0 |
Collected over Adverse event data were collected over the period of the study, 28 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NDE L68 StableFit® Punctal Plug | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| Event | NDE L68 StableFit® Punctal Plug |
|---|---|
| Clinically significant slit-lamp findingsEye disorders | 1/15 |
| Age, Customized(Participants) | NDE L68 StableFit® Punctal Plug |
|---|---|
| 20-<25 years | 1 |
| 25- <30 years | 4 |
| 30-<35 years | 4 |
| 45- <50 years | 2 |
| 55- <60 years | 2 |
| 60- <65 years | 2 |
| Sex: Female, Male(Participants) | NDE L68 StableFit® Punctal Plug |
|---|---|
| Female | 12 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | NDE L68 StableFit® Punctal Plug |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | NDE L68 StableFit® Punctal Plug |
|---|---|
| United States | 15 |
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Mati Therapeutics Inc.