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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280653
• Other study ID #: NDE68-19-01
• Status: Completed
• Phase: N/A
• Start date: August 28, 2019
• Est. completion date: December 11, 2019

Study information

• Verified date: December 2020
• Source: Mati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of the NDE L68 StableFit® punctal plug on the tear lake.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Eye Institute-Edgewood	Edgewood	Kentucky
United States	Ophthalmic Consultants of Long Island	Garden City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Mati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	7 days
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.	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	28 days