Evaluation of Reflex Tear Production

Alcon

Status: Terminated

Conditions: Dry Eye Disease

Treatments: Procedure: Cotton Swab Nasal Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06565624

DEF512-E004

Details and patient eligibility

About

The purpose of this study is to evaluate reflex tear production following cotton swab nasal stimulation in subjects with dry eye disease (DED).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 exclusion criteria may apply.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Nasal Stimulation

Experimental group

Description:

The Investigator will insert cotton swabs into both nostrils of the subject and gently probe the nasal middle cavities. Stimulation will stop once visible and obvious reflex tearing has begun.

Treatment:

Procedure: Cotton Swab Nasal Stimulation