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Dry EyeNCT04817085

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

A study testing Visant Medical Canalicular Plug and Commercially available canalicular plug in people with Dry Eye, run by Visant Medical, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for
Dry Eye
What is being tested?
Visant Medical Canalicular Plug and Commercially available canalicular plug
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
5 sitesUnited States
Study dates
6 Oct 2020to 9 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Andover Eye Associates

    Andover, Massachusetts, 01810

  • Piedmont Eye, Inc.

    Lynchburg, Virginia, 24502

  • See Clearly Vision

    McLean, Virginia, 22102

  • Eye Research Foundation, Inc.

    Newport Beach, California, 92663

  • Schwartz Laser Eye Center

    Scottsdale, Arizona, 85260

Other trials in United States

About this study

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

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

Read the 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
Being tested
Visant Medical Canalicular Plug, Commercially available canalicular plug
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visant Medical Canalicular PlugDevice

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

  • Commercially available canalicular plugDevice

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

Study groups in NCT04817085
Study groupRoleWhat they receive
Visant Medical Canalicular PlugExperimentalBilateral placement of the Visant Canalicular Plug inserted on Day 1
Receives: Device: Visant Medical Canalicular Plug
Commercially available canalicular plugActive comparatorBilateral placement of commercially available canalicular plug inserted on Day 1
Receives: Device: Commercially available canalicular plug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (10)

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

    Non-inferiority hypothesis. Scale of 0-100. Lower OSDI score means fewer symptoms.

    Measured: 3 months

  2. Mean change in tear meniscus height from baseline

    Null hypothesis of no improvement from baseline. Larger measurement equates to larger tear film.

    Measured: Month 3

  3. Mean change in OSDI score from baseline

    Null hypothesis of no improvement from baseline. Non-inferiority hypothesis. Scale of 0-100. Lower OSDI score means fewer symptoms.

    Measured: Month 3

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

    Null hypothesis of no improvement from baseline. Scale is 0-15. More staining is associated with more severe dry eye.

    Measured: Month 3

  5. Mean change in tear meniscus height from baseline

    Null hypothesis of no improvement from baseline. Larger measurement equates to larger tear film.

    Measured: Month 6

  6. Mean change in OSDI score from baseline

    Null hypothesis of no improvement from baseline. Non-inferiority hypothesis. Scale of 0-100. Lower OSDI score means fewer symptoms.

    Measured: Month 6

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

    Null hypothesis of no improvement from baseline. Scale is 0-15. More staining is associated with more severe dry eye.

    Measured: Month 6

  8. Mean change in tear break up time from baseline

    Null hypothesis of no improvement from baseline. Increased time equates to more stable tear film

    Measured: Month 3

  9. Mean change in Schirmer score from baseline

    Null hypothesis of no improvement from baseline. Higher Score using this continuous variable equates to larger tear film

    Measured: Month 6

  10. Mean change in tear break up time from baseline

    Null hypothesis of no improvement from baseline. Increased time equates to more stable tear film

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2021
  2. Study start6 Oct 2020
  3. Primary completion9 Feb 2022
  4. Study completion9 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04817085
Sponsor's protocol ID
D-348-CSP
Status last verified
Mar 2021
First submitted
2 Dec 2020
Last updated
6 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Visant Medical Canalicular Plug and Commercially available canalicular plug in people with Dry Eye, run by Visant Medical, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in Schirmer's score from baseline to Month 3 compared to commercially available plug (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04817085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.

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