Dry EyePhase 4NCT07606625
Ocular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment
A Phase 4 study testing Varenicline 0.03Mg/Spray Nasal Soln in people with Dry Eye and Meibomian Gland Dysfunction, run by University of California, Berkeley at 1 site in United States.
Trial summary
The purpose of this study is to examine the impact of nasal spray treatment on Meibomian gland function and ocular surface health in symptomatic dry eye patients with mild to moderate Meibomian gland dysfunction (MGD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Meibomian Gland Dysfunction
- What is being tested?
- Varenicline 0.03Mg/Spray Nasal Soln
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Is 18 years of age and has full legal capacity to volunteer (no max age requirement)
- Baseline Ocular Surface Disease Index (OSDI) >13
- Has mild to moderate MGD
- Has best corrected visual acuity of 20/40 or better
- Has had an oculo-visual examination in the last two years
- Is willing to continue other daily dry eye management regimen (e.g., warm compresses, and/or eyelid margin cleaning)
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- Is willing to discontinue other prescription medications for dry eye disease (DED) management
- Is willing to stop any topical eye drops before all planned visits
- Has read, understood, and completed the informed consent letter
Who cannot join
- Is participating in any other type of clinical or research study
- Is currently pregnant, nursing, lactating, or planning a pregnancy
- Is currently having >50% blockage of Meibomian glands in more than two eyelids or significant atrophy (i.e., severe MGD)
- Is currently using any topical ocular medications
- Has chronic or currently active sinus related problems
- Has blepharitis > grade 1
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- Has active ocular infections
- Has a condition or in a situation which, in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study
- Has received Rx DED treatment within one week of enrollment
- Has received any thermal or light-based DED treatment within 30 days of enrollment
- Has significant corneal epithelial defects
- Has abnormal eyelid anatomy
- Has corneal neuropathic pain
- Has chronic or recurrent epistaxis (nosebleeds), coagulation disorders, or other conditions that may have led to a clinically significant increased risk of bleeding
- Has any intraocular surgery including trabeculectomy (MIGS, laser, or small incision glaucoma surgery allowed), extraocular surgery in either eye within 3 months, or refractive surgery within 12 months of enrollment
- Has a known allergy to a product used in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
U.C. Berkeley Clinical Research Center
Berkeley, California, 94720
Meng C. Lin, OD, PhD, 510-643-9252, mlin@berkeley.edu
Laimeng Lee, OD, MS, 510-643-9252, laimenglee@berkeley.edu
About this study
Official title: The Impact of Varenicline Nasal Spray 0.03mg Dry Eye Treatment on Ocular Surface Health, Tear Film Stability, and Ocular Discomfort
The purpose of this study is to examine the impact of nasal spray treatment on Meibomian gland function and ocular surface health in symptomatic dry eye patients with mild to moderate Meibomian gland dysfunction (MGD).
Read the detailed description
Dry eye disease is a common condition that occurs when eyes do not produce enough tears or when the quality of the tears is poor causing tears to evaporate quickly off the eye. This can lead to symptoms such as dryness, burning, irritation, and/or blurred vision. Meibomian gland dysfunction is the most common cause of evaporative dry eye disease. The purpose of this study is to examine the impact of nasal spray treatment on Meibomian gland function and ocular surface health in symptomatic dry eye patients with mild to moderate Meibomian gland dysfunction (MGD). The nasal spray is FDA approved for the treatment of signs and symptoms of dry eye disease.
- Conditions
- Dry Eye, Meibomian Gland Dysfunction
- Being tested
- Varenicline 0.03Mg/Spray Nasal Soln
- Keywords
- Dry eye disease, Meibomian gland dysfunction, Varenicline, Nasal spray dry eye treatment, Tear lipid layer, Tear thinning, Tear production, Tear film stability, Ocular discomfort
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline 0.03Mg/Spray Nasal SolnDrug
After meeting eligibility criteria and signing informed consent, participants will be dispensed a 3-month supply of varenicline 0.03mg/spray nasal solution. Participants will take the nasal spray home and spray once in each nostril twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Nasal Spray Treatment Group | Experimental | Participants to be dispensed varenicline nasal spray 0.03mg solution and self-administer one spray in each nostril twice daily, approximately 12 hours apart, for 3 months. Receives: Drug: Varenicline 0.03Mg/Spray Nasal Soln |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tear lipid layer thickness
Change from baseline in the thickness of the tear lipid layer in microns measured using the EASYTEARView+ Dacryscope. An increase in tear lipid layer thickness is considered a positive treatment effect
Measured: Measured at baseline, 1-month, and 3 months
Change in tear thinning rate
Change from baseline in the rate of tear thinning in %/sec measured using the EASYTEARView+ Dacryscope. A decrease in the rate of tear thinning is considered a positive treatment effect
Measured: Measured at baseline, 1-month, and 3 months
Secondary outcomes (4)
Change in Meibomian gland function
Change from baseline in the clinical grade of meibum expressed from the Meibomian glands using the Korb Meibomian Gland Evaluator. Clinical grades assigned based on a 0-30 point scale, with 30 indicating copious, clear meibum and 0 indicating no meibum expressed (blocked orifices). An increase in score indicates improved gland function.
Measured: Measured at baseline, 1-month, and 3 months
Change in tear production rate
Change from baseline in the rate of tear production in µL/min, measured using the Schirmer Tear Test. An increase in tear production is considered a positive treatment effect.
Measured: Measured at baseline, 1-month, and 3 months
Change in tear breakup time
Change from baseline in non-invasive tear breakup time in seconds, measured using the Oculus Keratograph 5M. An increase in tear breakup time is considered a positive treatment effect.
Measured: Measured at baseline, 1-month, and 3 months
Change in Ocular Comfort
Change from baseline in ocular discomfort, measured using the Ocular Surface Disease Index (OSDI) on a 0-100 scale. A decrease in OSDI score is considered a positive treatment effect.
Measured: Measured at baseline, 1-month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start6 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Viatris Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606625
- Sponsor's protocol ID
- 15446-MCLin
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data are considered proprietary intellectual property of Viatris, Inc.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Varenicline Nasal Spray 0.03mg Dry Eye Treatment on Ocular Surface Health, Tear Film Stability, and Ocular Discomfort
- ClinicalTrials.gov ID
- NCT07606625
- Acronym / sponsor ID
- 15446-MCLin
- Conditions
- Dry Eye, Meibomian Gland Dysfunction
- Keywords
- Dry eye disease, Meibomian gland dysfunction, Varenicline, Nasal spray dry eye treatment, Tear lipid layer, Tear thinning, Tear production, Tear film stability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Viatris Inc.
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 May 2026 (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 examine the impact of nasal spray treatment on Meibomian gland function and ocular surface health in symptomatic dry eye patients with mild to moderate Meibomian gland dysfunction (MGD).
Detailed description
Dry eye disease is a common condition that occurs when eyes do not produce enough tears or when the quality of the tears is poor causing tears to evaporate quickly off the eye. This can lead to symptoms such as dryness, burning, irritation, and/or blurred vision. Meibomian gland dysfunction is the most common cause of evaporative dry eye disease. The purpose of this study is to examine the impact of nasal spray treatment on Meibomian gland function and ocular surface health in symptomatic dry eye patients with mild to moderate Meibomian gland dysfunction (MGD). The nasal spray is FDA approved for the treatment of signs and symptoms of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal Spray Treatment Group | Experimental | Drug: Varenicline 0.03Mg/Spray Nasal SolnParticipants to be dispensed varenicline nasal spray 0.03mg solution and self-administer one spray in each nostril twice daily, approximately 12 hours apart, for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is 18 years of age and has full legal capacity to volunteer (no max age requirement)
- Baseline Ocular Surface Disease Index (OSDI) >13
- Has mild to moderate MGD
- Has best corrected visual acuity of 20/40 or better
- Has had an oculo-visual examination in the last two years
Key exclusion criteria (16 listed)
- Is participating in any other type of clinical or research study
- Is currently pregnant, nursing, lactating, or planning a pregnancy
- Is currently having >50% blockage of Meibomian glands in more than two eyelids or significant atrophy (i.e., severe MGD)
- Is currently using any topical ocular medications
- Has chronic or currently active sinus related problems
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 |
|---|---|---|
| Varenicline 0.03Mg/Spray Nasal SolnAfter meeting eligibility criteria and signing informed consent, participants will be dispensed a 3-month supply of varenicline 0.03mg/spray nasal solution. Participants will take the nasal spray home and spray once in each nostril twice daily for 3 months | Drug | Nasal Spray Treatment Group |
Primary outcome
Change in tear lipid layer thickness
Time frame: Measured at baseline, 1-month, and 3 months
Change from baseline in the thickness of the tear lipid layer in microns measured using the EASYTEARView+ Dacryscope. An increase in tear lipid layer thickness is considered a positive treatment effect
Change in tear thinning rate
Time frame: Measured at baseline, 1-month, and 3 months
Change from baseline in the rate of tear thinning in %/sec measured using the EASYTEARView+ Dacryscope. A decrease in the rate of tear thinning is considered a positive treatment effect
4 secondary outcomes
Change in Meibomian gland function
Time frame: Measured at baseline, 1-month, and 3 months
Change in tear production rate
Time frame: Measured at baseline, 1-month, and 3 months
Change in tear breakup time
Time frame: Measured at baseline, 1-month, and 3 months
Change in Ocular Comfort
Time frame: Measured at baseline, 1-month, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No. Data are considered proprietary intellectual property of Viatris, Inc.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline 0.03Mg/Spray Nasal Soln in people with Dry Eye and Meibomian Gland Dysfunction, run by University of California, Berkeley 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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng C. Lin, OD, PhD (510-643-9252, mlin@berkeley.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tear lipid layer thickness (time frame: Measured at baseline, 1-month, and 3 months). The study lists 2 primary outcomes in all. 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 27 May 2026.