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

NCT04280653 | Completed Results FDA Device

• 1 other identifier: NDE68-19-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days

  28 days

Study Arms (1)

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

Device: NDE L68 StableFit® Punctal Plug

Interventions

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.

Also known as: L-shaped Punctal Plug

NDE L68 StableFit® punctal plug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• A subject must be able to read, comprehend and be willing to give HIPAA authorization and informed consent
• A subject must be willing to have a punctal plug inserted in the lower punctum of one of their eyes
• 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

You may not qualify if:

• 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
• A subject with a history of intolerance to punctal plugs
• A subject with structural lid abnormalities (e.g., ectropion, entropion) in the planned study eye
• A subject with any clinically significant lid, conjunctival or corneal findings in the planned study eye at the baseline visit
• A subject with a severe dry eye condition
• A subject experiencing epiphora in the planned study eye
• A subject experiencing any clinically significant ocular pain or discomfort in or around either eye at the baseline visit

Sponsors & Collaborators

• Mati Therapeutics Inc.: lead

Study Sites (2)

Cincinnati Eye Institute-Edgewood

Edgewood, Kentucky, 41017, United States

Location

Ophthalmic Consultants of Long Island

Garden City, New York, 11530, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Deepank Utkhede
• Organization: Mati Therapeutics Inc.

dutkhede@matitherapeutics.com

778-991-3301

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 21, 2020
• Study Start: August 28, 2019
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: December 8, 2020
• Results First Posted: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)