Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NDE L68 StableFit® punctal plug | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NDE L68 StableFit® Punctal Plug | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days | Questionnaire | 28 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Eye Institute-Edgewood | Edgewood | Kentucky | 41017 | United States | ||
| Ophthalmic Consultants of Long Island |
Not provided
Not provided
Not provided
Not provided
Not provided
There was no wash out or run-in period in this study. There was only 1 arm in this study.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | mean percent change from baseline | 7 days |
|
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:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically significant slit-lamp findings | Eye disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deepank Utkhede | Mati Therapeutics Inc. | 778-991-3301 | dutkhede@matitherapeutics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2019 | Nov 9, 2020 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Garden City |
| New York |
| 11530 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Posted | Mean | Full Range | mean percent change from baseline | 28 days |
|
|
|
| Secondary | Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days | Questionnaire | 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 | Posted | Count of Participants | Participants | 28 days |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
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.
| Somewhat Unacceptable |
|
| Unacceptable |
|
| Extremely Unacceptable |
|