Dry Eye Disease
Conditions
Keywords
Reflex Tear Production
Brief summary
The purpose of this study is to evaluate reflex tear production following cotton swab nasal stimulation in subjects with dry eye disease (DED).
Detailed description
The primary analysis will assess the change from baseline (pre- versus immediately post-cotton swab nasal stimulation) in tear meniscus height (TMH) using optical coherence tomography (OCT). This study will consist of one visit on a single day.
Interventions
PROCEDURECotton Swab Nasal Stimulation
Nostril probing for the purpose of producing reflex tearing
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported. * Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms. * Corrected Visual Acuity (Snellen) 20/200 or better in both eyes. * Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history. * Able, as assessed by the investigator, and willing to follow study instructions. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration). * Use of artificial tears within 2 hours of the Study Visit. * History of ocular surgery within 1 year of the Study Visit. * Use of contact lenses in either eye within 7 days of the Study Visit. * Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit. * Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in TMH immediately following stimulation | Day 1 pre-stimulation (Baseline); Day 1 immediately post-stimulation | TMH (the distance between the line of reflection along the top of the tear prism to the edges of the eyelids) will be measured in millimeters using OCT, a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. TMH will be assessed prior to nasal stimulation and upon completion of nasal stimulation. Only one eye will be assessed by OCT. |
Countries
United States
Outcome results
None listed