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

NCT ID: NCT04817085

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2022-02-09

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.

Detailed Description

The objective of this study is to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug over 6 months of subject follow-up.

Study subjects who are eligible for enrollment and have provided written informed consent will be randomized in a 2:1 ratio (i.e., 2 subjects randomized to the Visant Medical Canalicular Plug for every 1 subject randomized to a commercially available canalicular plug). All study subjects will be treated bilaterally with plugs placed in the inferior canaliculi.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Visant Medical Canalicular Plug

Bilateral placement of the Visant Canalicular Plug inserted on Day 1

Group Type: EXPERIMENTAL

Visant Medical Canalicular Plug

Intervention Type: DEVICE

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

Commercially available canalicular plug

Bilateral placement of commercially available canalicular plug inserted on Day 1

Group Type: ACTIVE_COMPARATOR

Commercially available canalicular plug

Intervention Type: DEVICE

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

Interventions

Visant Medical Canalicular Plug

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

Intervention Type: DEVICE

Commercially available canalicular plug

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Twenty-two (22) years of age or older

2. BCDVA of 20/40 or better in each eye

3. Both eyes with a baseline Schirmer's test with anesthetic ≤ 10 mm/5 minutes

4. Presence of corneal staining in both eyes in any of the 5 areas defined by the NEI/Industry Workshop Scale

5. Baseline OSDI score of at least 23 with no more than 3 responses of "not applicable"

6. Patent bilateral lacrimal drainage system as demonstrated by punctal irrigation

7. 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

8. Willing and able to sign informed consent and HIPAA authorization, follow study instructions, and complete all study visits.

Exclusion Criteria

1. Use of ophthalmic cyclosporine (Restasis) within 6 months or lifitegrast (Xiidra) within 3 months prior to Day 0 in either eye

2. History of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery in either eye

3. Corneal transplant in either eye

4. Ocular surgery (such as cataract surgery or LASIK) in either eye within six months of the Baseline Visit

5. 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)

6. 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

7. Active severe systemic allergy, seasonal allergies, rhinitis or sinusitis requiring treatment (i.e., antihistamines, decongestants, oral or aerosol steroids)

8. Use of steroids, including administration by systemic or topical ocular routes (dermatologic steroids not applied to the eyelids and inhaled steroids are allowed)

9. Participation in a clinical trial during the past 30 days

10. Women who are pregnant, planning a pregnancy, or nursing at study entry

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Visant Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Albright

Role: STUDY_DIRECTOR

Ora Clinical Research Organization

Locations

Schwartz Laser Eye Center

Scottsdale, Arizona, United States

Eye Research Foundation, Inc.

Newport Beach, California, United States

Andover Eye Associates

Andover, Massachusetts, United States

Piedmont Eye, Inc.

Lynchburg, Virginia, United States

See Clearly Vision

McLean, Virginia, United States

Countries

United States

Other Identifiers

D-348-CSP

Identifier Type: -

Identifier Source: org_study_id