| Eligibility |
Inclusion Criteria:
1. Male or female aged 22 or older complaining of ocular dryness who report having to use
artificial tears or lubricants.
2. Both of the following conditions:
- Baseline symptoms score of 23 or higher on the OSDI questionnaire; and
- OSDI Questionnaire has 3 or fewer responses of "not applicable"
3. 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.
4. Willing and able to comply with the study procedures and follow-up.
5. Willing and able to provide informed consent.
Exclusion Criteria:
1. 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).
2. 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.
3. Presence of - or unverified removal of - other canalicular occlusion devices.
4. Chronic allergic rhinitis
5. Allergic to study materials, supplies and medication.
6. Contraindication to topical anesthesia.
7. Actively using a topical medication (such as steroids and immunosuppressants) for
which the use of a plug may cause complications, regardless of dosage adjustment.
8. 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.
9. Co-existing health condition(s), either ocular or non-ocular that, in the judgement of
the investigator could affect the safety or effectiveness of treatment, the compliance
of the participant to the protocol, or other factors which may confound validity of
study data collection or analysis. For example, participants who are pregnant or
nursing, have pterygium, or uncontrolled blepharitis for which artificial lubricants
do not provide relief are excluded. Unless post-menopausal or medically sterile (e.g
hysterectomy, bilateral tubal ligation, bilateral oophorectomy), female participants
must have a negative urine pregnancy test (UPT) on Day 0 of the study and should
utilize a medically acceptable form of contraception over the course of the study.
10. Use of drugs under any of the following conditions:
- Change in dry eye medication (e.g., Restasis or Xiidra) within 60 days prior to
enrollment (i.e., participant drug use must be stable prior to the study. They
may not be enrolled if they began drug use within the past 60 days of assessment
or if they intend to begin prescription drug use during the study); or
- Systemic medication(s) (other than anti-histamines) that is known to cause ocular
dryness (e.g. diuretics, anti-hypertensives, anti-depressants, hormone therapy)
and whose dose of this medication(s) has not been stable within 30 days prior to
enrollment. There must be no anticipated adjustments to the dose of these
medications for the duration of the trial; or
- Oral tetracyclines or azithromycin between enrollment and 30 days prior, unless
their dosage will remain the same throughout the study; or
- Topical ophthalmic antibiotics, anti-glaucoma medications, steroids,
non-steroidal anti-inflammatory medications between enrollment and 30 days prior
to enrollment, with the exception that patients who are newly prescribed
short-term use (15 days or less) anti-inflammatories (e.g., corticosteroids) by
the investigator during their screening visit may be included
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