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 range22 Years

SexALL

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.
✕. Presence of - or unverified removal of - other canalicular occlusion devices.
✕. Chronic allergic rhinitis
✕. Allergic to study materials, supplies and medication.
✕. Contraindication to topical anesthesia.
✕. Actively using a topical medication (such as steroids and immunosuppressants) for which the use of a plug may cause complications, regardless of dosage adjustment.
✕. Participation in another ophthalmic clinical trial within three months prior to enrollment. Participant must also be willing to refrain from another ophthalmic study for the duration of the study.

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