An Evaluation of the Clinical Utility and Safety of the Visant Medical Canalicular Plug

NCT04817085 | Completed FDA Device

• 1 other identifier: D-348-CSP
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 5

Brief Summary

This study is designed to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Mean change in Schirmer's score from baseline to Month 3 compared to commercially available plug

  Non-inferiority hypothesis. Higher Score using this continuous variable equates to larger tear film

  3 months

Secondary Outcomes (10)

• Proportion of responders achieving improvement from Baseline in Ocular Surface Disease Index (OSDI) score by a Minimal Clinically Important Difference (MCID).

  3 months

• Mean change in tear meniscus height from baseline

  Month 3

• Mean change in OSDI score from baseline

  Month 3

• Mean change in corneal staining score from baseline (NEI workshop scale)

  Month 3

• Mean change in tear meniscus height from baseline

  Month 6

Study Arms (2)

Visant Medical Canalicular Plug

EXPERIMENTAL

Bilateral placement of the Visant Canalicular Plug inserted on Day 1

Device: Visant Medical Canalicular Plug

Commercially available canalicular plug

ACTIVE COMPARATOR

Bilateral placement of commercially available canalicular plug inserted on Day 1

Device: Commercially available canalicular plug

Interventions

Visant Medical Canalicular Plug DEVICE

Plug is inserted into the inferior canaliculi and assessed for 6 months

Visant Medical Canalicular Plug

Commercially available canalicular plug DEVICE

Plug is inserted into the inferior canaliculi and assessed for 6 months

Commercially available canalicular plug

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Twenty-two (22) years of age or older
• BCDVA of 20/40 or better in each eye
• Both eyes with a baseline Schirmer's test with anesthetic ≤ 10 mm/5 minutes
• Presence of corneal staining in both eyes in any of the 5 areas defined by the NEI/Industry Workshop Scale
• Baseline OSDI score of at least 23 with no more than 3 responses of "not applicable"
• Patent bilateral lacrimal drainage system as demonstrated by punctal irrigation
• If female, subject must be post-menopausal, medically sterile (e.g hysterectomy, bilateral tubal ligation, bilateral oophorectomy) or have negative urine pregnancy test (UPT) on Day 0 of the study and agree to utilize a medically acceptable form of contraception over the course of the study
• Willing and able to sign informed consent and HIPAA authorization, follow study instructions, and complete all study visits.

You may not qualify if:

• Use of ophthalmic cyclosporine (Restasis) within 6 months or lifitegrast (Xiidra) within 3 months prior to Day 0 in either eye
• History of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery in either eye
• Corneal transplant in either eye
• Ocular surgery (such as cataract surgery or LASIK) in either eye within six months of the Baseline Visit
• A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease)
• The history or presence of any ocular disorder or condition in either eye that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection (except mild blepharitis), conjunctivitis or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; history of ocular herpetic infection; evidence of keratoconus; lid or lacrimal cancer
• Active severe systemic allergy, seasonal allergies, rhinitis or sinusitis requiring treatment (i.e., antihistamines, decongestants, oral or aerosol steroids)
• Use of steroids, including administration by systemic or topical ocular routes (dermatologic steroids not applied to the eyelids and inhaled steroids are allowed)
• Participation in a clinical trial during the past 30 days
• Women who are pregnant, planning a pregnancy, or nursing at study entry

Sponsors & Collaborators

• Visant Medical, Inc.: lead

Study Sites (5)

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

Eye Research Foundation, Inc.

Newport Beach, California, 92663, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Piedmont Eye, Inc.

Lynchburg, Virginia, 24502, United States

Location

See Clearly Vision

McLean, Virginia, 22102, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Roger Albright

  Ora Clinical Research Organization

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be masked to their assignment to either the treatment or control group. Clinical personnel who perform clinical assessments will also be masked to the subjects' assignment to either the treatment or control group ("masked evaluators"). The eye care professional who inserts the test and control devices will not be masked and will not be eligible to perform follow-up evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All study subjects will receive treatment. Study subjects will be randomized (2:1 ratio) with 2 subjects randomized to receive the Visant Medical Canalicular Plug for every 1 subject randomized to receive the commercially available canalicular plug.

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: March 25, 2021
• Study Start: October 6, 2020
• Primary Completion: February 9, 2022
• Study Completion: February 9, 2022
• Last Updated: June 6, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)