CompletedNot Applicable

Evaluating a Device for Blocking the Tear Duct

Mexico33 participantsStarted 2023-03-07

Plain-language summary

Participants will receive a tear duct plug to see if their eye comfort improves.

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

. Male or female aged 22 or older complaining of ocular dryness who report having to use artificial tears or lubricants.
. Both of the following conditions:
. Basal tear secretion (Schirmer I Test with anesthesia) \< 10mm/5 minutes (in one of the two eyes). The eye with the lower score is the study eye.
. Willing and able to comply with the study procedures and follow-up.
. Willing and able to provide informed consent.

Exclusion criteria

. Presence or history of chronic or current, acute ocular inflammation or infection, aside from mild blepharitis or inflammation associated with primary dry eye or disorders which are known to cause dry eyes (e.g. Sjrögens Syndrome).
. The presence of any lacrimal occlusion, ocular disorder, or condition in either eye, conjunctiva, or lacrimal system that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., corneal transplant, routine ocular injections, recent ocular surgery, ectropion, surgical procedure such as cautery, or past canalicular surgery, significant corneal or conjunctival scarring, pterygium or nodular pinguecula; active ocular herpetic infection; lid or lacrimal cancer; clinically significant corneal dystrophy or other disorder which may cause rapid degeneration of visual acuity, such as anterior (epithelial) basement membrane corneal dystrophy, clinical keratoconus, or active, wet macular degeneration.

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

Mean change in basal tear secretion (Schirmer I test, with anesthesia) for designated study eye from baseline to Week 12

Timeframe: 3 months

Trial details

NCT IDNCT05748951

SponsorAesculaTech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-22

View on ClinicalTrials.gov More Dry Eye trials