Evaluation of Reflex Tear Production

NCT ID: NCT06565624

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2024-11-07

Brief Summary

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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

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nasal Stimulation

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.

Group Type EXPERIMENTAL

Cotton Swab Nasal Stimulation

Intervention Type PROCEDURE

Nostril probing for the purpose of producing reflex tearing

Interventions

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Cotton Swab Nasal Stimulation

Nostril probing for the purpose of producing reflex tearing

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Lead, Pharma

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Eye Research Foundation

Newport Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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DEF512-E004

Identifier Type: -

Identifier Source: org_study_id

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