An Evaluation of the Clinical Utility and Safety of the Visant Medical Canalicular Plug (NCT04817085) | Clinical Trial Compass
CompletedNot Applicable
An Evaluation of the Clinical Utility and Safety of the Visant Medical Canalicular Plug
United States156 participantsStarted 2020-10-06
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Use of ophthalmic cyclosporine (Restasis) within 6 months or lifitegrast (Xiidra) within 3 months prior to Day 0 in either eye
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change in Schirmer's score from baseline to Month 3 compared to commercially available plug
. 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)