Clinical trial NCT04817085: An Evaluation of the Clinical Utility and Safety of the Visant Medical Canalicular Plug
Official title: Prospective Multicenter, Randomized, Double-Masked, Controlled Trial to Evaluate Clinical Utility and Safety of the Visant Medical Canalicular Device in Subjects Who Are Candidates for Occlusion With Punctal or Canalicular Plugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Visant Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 156
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change in Schirmer's score from baseline to Month 3 compared to commercially available plug
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of responders achieving improvement from Baseline in Ocular Surface Disease Index (OSDI) score by a Minimal Clinically Important Difference (MCID).
timeFrame: 3 months
measure: Mean change in tear meniscus height from baseline
timeFrame: Month 3
measure: Mean change in OSDI score from baseline
timeFrame: Month 3
measure: Mean change in corneal staining score from baseline (NEI workshop scale)
timeFrame: Month 3
measure: Mean change in tear meniscus height from baseline
timeFrame: Month 6
measure: Mean change in OSDI score from baseline
timeFrame: Month 6
measure: Mean change in corneal staining score from baseline (NEI workshop scale)
timeFrame: Month 6
measure: Mean change in tear break up time from baseline
timeFrame: Month 3
measure: Mean change in Schirmer score from baseline
timeFrame: Month 6
measure: Mean change in tear break up time from baseline
timeFrame: Month 6
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Newport Beach
country: United States
facility: Eye Research Foundation, Inc.
state: California
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Lynchburg
country: United States
facility: Piedmont Eye, Inc.
state: Virginia
city: McLean
country: United States
facility: See Clearly Vision
state: Virginia
Study officials:
affiliation: Ora Clinical Research Organization
name: Roger Albright
role: STUDY_DIRECTOR
References: