Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Viatris Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline 0.03Mg/Spray Nasal Soln | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 at baseline, 1-month, and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at baseline, 1-month, and 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng C. Lin, OD, PhD | Contact | 510-643-9252 | mlin@berkeley.edu | |
| Laimeng Lee, OD, MS | Contact | 510-643-9252 | laimenglee@berkeley.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.C. Berkeley Clinical Research Center | Recruiting | Berkeley | California | 94720 | United States |
Data are considered proprietary intellectual property of Viatris, Inc.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 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 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 at baseline, 1-month, and 3 months |
| D011810 | Quinoxalines |