Status:
TERMINATED
Evaluation of Reflex Tear Production
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 stud...
Eligibility Criteria
Inclusion
- Key
- 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
- 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 exclusion criteria may apply.
Key Trial Info
Start Date :
October 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06565624
Start Date
October 17 2024
End Date
November 7 2024
Last Update
January 23 2025
Active Locations (1)
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1
Eye Research Foundation
Newport Beach, California, United States, 92663