Nasal Stimulation for Dry Eye Syndrome

N/A

Recruiting

Research Sponsored by Alcon Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms

Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported

Must not have

Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 pre-stimulation (baseline); day 1 immediately post-stimulation

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to measure how much tears are produced when the inside of the nose is stimulated with a cotton swab in people with dry eye disease.

Who is the study for?

This trial is for individuals who have had dry eye disease within the last year, whether diagnosed by a doctor or self-reported. Participants should have used or wanted to use artificial tears in the past 6 months and must have decent vision with correction. They need to be generally healthy based on medical history and eye exams, and able to follow study instructions.

What is being tested?

The study aims to assess how well reflex tear production works after stimulating the nose with a cotton swab in people suffering from dry eye syndrome. It's designed to see if this method can help measure tear production effectively.

What are the potential side effects?

Since this intervention involves only nasal stimulation using a cotton swab, side effects are expected to be minimal but may include temporary discomfort or sneezing during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have used or wanted to use artificial tears for dry eyes in the last 6 months.

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I have had dry eye disease in the past year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious eye conditions besides dry eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 pre-stimulation (baseline); day 1 immediately post-stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 pre-stimulation (baseline); day 1 immediately post-stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 pre-stimulation (baseline); day 1 immediately post-stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in TMH immediately following stimulation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nasal StimulationExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met