Dry Eye DiseaseNCT06565624
Evaluation of Reflex Tear Production
A study testing Cotton Swab Nasal Stimulation in people with Dry Eye Disease, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate reflex tear production following cotton swab nasal stimulation in subjects with dry eye disease (DED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Cotton Swab Nasal Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2024to 7 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Eye Research Foundation
Newport Beach, California, 92663
About this study
The purpose of this study is to evaluate reflex tear production following cotton swab nasal stimulation in subjects with dry eye disease (DED).
Read the 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.
- Conditions
- Dry Eye Disease
- Being tested
- Cotton Swab Nasal Stimulation
- Keywords
- Reflex Tear Production
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cotton Swab Nasal StimulationProcedure or surgery
Nostril probing for the purpose of producing reflex tearing
| Study group | Role | What they receive |
|---|---|---|
| Nasal Stimulation | Experimental | 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. Receives: Procedure: Cotton Swab Nasal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in TMH immediately following 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.
Measured: Day 1 pre-stimulation (Baseline); Day 1 immediately post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start17 Oct 2024
- Primary completion7 Nov 2024
- Study completion7 Nov 2024
Why it stopped: Management decision post planned futility analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Pharma, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565624
- Sponsor's protocol ID
- DEF512-E004
- Status last verified
- Jan 2025
- First submitted
- 20 Aug 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reflex Tear Production
- ClinicalTrials.gov ID
- NCT06565624
- Acronym / sponsor ID
- DEF512-E004
- Conditions
- Dry Eye Disease
- Keywords
- Reflex Tear Production
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Management decision post planned futility analysis
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal Stimulation | Experimental | Procedure: Cotton Swab Nasal StimulationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cotton Swab Nasal StimulationNostril probing for the purpose of producing reflex tearing | Procedure or surgery | Nasal Stimulation |
Primary outcome
Change from baseline in TMH immediately following stimulation
Time frame: 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.
Results and safety
The study was stopped early (reason given: Management decision post planned futility analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Pharma study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cotton Swab Nasal Stimulation in people with Dry Eye Disease, run by Alcon Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Management decision post planned futility analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in TMH immediately following stimulation (time frame: Day 1 pre-stimulation (Baseline); Day 1 immediately post-stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.