Dry Eye Syndromes
Conditions
Brief summary
To evaluate the effect of the NDE L68 StableFit® punctal plug on the tear lake.
Detailed description
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.
Interventions
DEVICENDE 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.
Sponsors
Mati Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. A male or female subject, 18 years of age or older, in good general health at the time of the baseline examination, who may or may not have a mild to moderate dry eye condition 2. A subject must be able to read, comprehend and be willing to give HIPAA authorization and informed consent 3. A subject must be willing to have a punctal plug inserted in the lower punctum of one of their eyes 4. A subject must be willing to comply with all study instructions, agree to make all office appointments, and complete the entire course of the study
Exclusion criteria
1. A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in the planned study eye 2. A subject with a history of intolerance to punctal plugs 3. A subject with structural lid abnormalities (e.g., ectropion, entropion) in the planned study eye 4. A subject with any clinically significant lid, conjunctival or corneal findings in the planned study eye at the baseline visit 5. A subject with a severe dry eye condition 6. A subject experiencing epiphora in the planned study eye 7. A subject experiencing any clinically significant ocular pain or discomfort in or around either eye at the baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days | 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. |
| Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days | 28 days | Questionnaire |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
There was no wash out or run-in period in this study. There was only 1 arm in this study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | NDE L68 StableFit® Punctal Plug |
|---|---|
| Age, Customized 20-<25 years | 1 Participants |
| Age, Customized 25- <30 years | 4 Participants |
| Age, Customized 30-<35 years | 4 Participants |
| Age, Customized 45- <50 years | 2 Participants |
| Age, Customized 55- <60 years | 2 Participants |
| Age, Customized 60- <65 years | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: 28 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NDE L68 StableFit® Punctal Plug | Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days | 143 mean percent change from baseline |
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NDE L68 StableFit® Punctal Plug | Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days | 129 mean percent change from baseline |
Secondary
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
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NDE L68 StableFit® Punctal Plug | 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 |
| NDE L68 StableFit® Punctal Plug | 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 |
| NDE L68 StableFit® Punctal Plug | 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 |
| NDE L68 StableFit® Punctal Plug | 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 |
| NDE L68 StableFit® Punctal Plug | 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 |
| NDE L68 StableFit® Punctal Plug | 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 |