Ocular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment

University of California (UC), Berkeley

Status and phase: Enrolling; Phase 4

Conditions: Dry Eye; Meibomian Gland Dysfunction

Treatments: Drug: Varenicline 0.03Mg/Spray Nasal Soln

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07606625

15446-MCLin

Details and patient eligibility

About

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).

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Nasal Spray Treatment Group

Experimental group

Description:

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.

Treatment:

Drug: Varenicline 0.03Mg/Spray Nasal Soln