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New treatment option for Dry Eye
Official title Ocular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment
ClinicalTrials.gov ID: NCT07606625
What this study is testing
What is Varenicline 0.03Mg/Spray Nasal Soln?
Varenicline 0.03Mg/Spray Nasal Soln is an investigational medicine, given as an once-daily, being studied as a potential treatment for dry eye.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Berkeley, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berkeley, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.