Dry Eye, Meibomian Gland Dysfunction
Conditions
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
Brief 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).
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.
Interventions
DRUGVarenicline 0.03Mg/Spray Nasal Soln
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
Sponsors
University of California, Berkeley
Viatris Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in tear lipid layer thickness | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Meibomian gland function | Measured at baseline, 1-month, and 3 months | 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. |
| Change in tear production rate | Measured at baseline, 1-month, and 3 months | 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. |
| Change in tear breakup time | Measured at baseline, 1-month, and 3 months | 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. |
| Change in Ocular Comfort | Measured at baseline, 1-month, and 3 months | 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. |
Countries
United States
Contacts
CONTACTMeng C. Lin, OD, PhD
CONTACTLaimeng Lee, OD, MS
Outcome results
None listed