Sunflower Lecithin for Dry Eye Syndrome

No longer recruiting at 1 trial location

Overseen By Keith Wroblowski, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Must not be taking: Anticholinergics, Tetracyclines, Corticosteroids

Disqualifiers: Ocular disease, Severe illness, Smoking, others

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sunflower lecithin supplements can improve the function of meibomian glands in adults with dry eye disease. Meibomian glands produce oils that prevent eyes from drying out, and the study aims to determine if sunflower lecithin enhances their function. Participants will take either sunflower lecithin or a placebo (olive oil) to compare results. This trial suits adults diagnosed with dry eye in both eyes who experience symptoms like dryness and irritation. As an unphased trial, it offers participants the opportunity to contribute to important research that could lead to new insights and potential treatments for dry eye disease.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, such as oral tetracycline or corticosteroids, and avoid regular use of strongly anticholinergic drugs. If you are on these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that sunflower lecithin is generally safe for use. Studies have found no harmful substances at the tested levels. Safety data sheets, which detail product safety, confirm no expected health risks when sunflower lecithin is used as directed. Under normal conditions, it is well-tolerated and unlikely to cause negative effects. While individual reactions can vary, available evidence suggests that sunflower lecithin is safe to consume. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for dry eye disease, which often include artificial tears or prescription medications like cyclosporine eye drops, sunflower lecithin is a natural supplement. Researchers are excited about sunflower lecithin because it may improve meibomian gland function, which is crucial for maintaining a healthy tear film and eye comfort. This unique approach targets the root cause of dry eyes by enhancing the lipid layer of tears, potentially offering a more holistic and side-effect-free alternative to conventional therapies.

What evidence suggests that sunflower lecithin might be an effective treatment for dry eye disease?

Research shows that sunflower lecithin, which participants in this trial may receive, is rich in certain fats that help maintain eye health by preventing oil separation. This may enhance the function of the meibomian glands, crucial for keeping eyes moist. Although specific studies on dry eye disease are limited, sunflower lecithin has been found to aid other health issues, such as metabolism and digestion. These findings suggest that sunflower lecithin might also benefit those with dry eyes by improving gland function and eye moisture. ^{6 7 8 9 10}

Who Is on the Research Team?

David Belyea, MD

Principal Investigator

The George Washington University

Are You a Good Fit for This Trial?

Inclusion Criteria

Best-corrected visual acuity (BCVA, Snellen) of 20/40 or better in each eye

Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions

Age greater than 18 at the time of informed consent

Exclusion Criteria

Evidence of acute ocular infection and⁄or intraocular inflammation within 1 month prior to the onset of this study

Ocular surgery within the last 6 months

Patients treated with topical ocular, steroidal or non-steroidal, anti-inflammatory treatment within the last month

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily doses of sunflower lecithin or placebo for 90 days

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sunflower Lecithin

How Is the Trial Designed?

Group I: Sunflower Lecithin Experimental Treatment 1 Intervention

Total 4800 mg sunflower lecithin per day taken in 4 softgel capsules

Group II: Olive Oil Placebo Group 1 Intervention

Total 4000 mg olive oil per day taken in 4 softgel capsules

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Virginia Lions Institute Foundation

Collaborator

Trials

1

Recruited

30+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11246377/

Lecithin and cardiovascular health: a comprehensive review

Lecithin offers potential health benefits, including cognitive enhancement through its choline content [8–10], liver protection from toxins [9, ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39598208/

Positive Outcomes of Supplementation with Lecithin-Based ...

In IBS subjects, the intervention with CUBO and LFD shows a significantly higher reduction in SBD, abdominal pain, and bloating compared to LFD and placebo.

3.

frontiersin.org

frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1497844/full

Oat polar lipids and sunflower lecithin similarly improve ...

Our study demonstrated that both LPL and OPL had beneficial effects on postprandial glucose and insulin responses, and appetite regulating gut hormones.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2590157525010235

Characterization and application of lecithin powders from ...

Sunflower lecithin yielded a higher phospholipid content (30.49 %). •. Sunflower lecithin was more effective in reducing oil separation, ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06407609

Positive Outcomes of the Supplementation With Lecithin- ...

The formula-tion in sunflower lecithin (Phytosome) of Curcuma longa and Boswellia serrata demonstrated beneficial effects on intestinal microbiota.

6.

praannaturals.com

praannaturals.com/downloads/msds/SDS_Organic_Sunflower_Lecithin_Liquid_ORGSUNLECCN881_100.pdf

Organic Sunflower Lecithin Liquid

EMERGENCY OVERVIEW: This product is a dark brown viscous liquid with a characteristic odor. Health Hazards: None expected when used under ...

7.

dcfinechemicals.com

dcfinechemicals.com/catalogo/Hojas%20de%20seguridad%20(EN)/112113-SDS-EN.pdf

Safety Data Sheet

In the application area, smoking, eating, and drinking must be prohibited. Follow legislation on occupational health and safety. Keep the product in containers ...

8.

docs.thesage.com

docs.thesage.com/sds/507-103%20Lecithin%20Sunflower%20SDS.pdf

Lecithin, Sunflower

This product, as supplied, does not contain any hazardous materials with occupational exposure limits established by the region specific regulatory bodies. 8.2 ...

9.

bulknaturaloils.com

bulknaturaloils.com/sunflower-lecithin-liquid-non-gmo-s1608.html?srsltid=AfmBOooGJq0dI6vKx-ndk2tBa6_K9meVgL31Nil7rp_5xh--D925JTQw

Sunflower Lecithin - Liquid Non-GMO

... Safety Data Sheet; and compliance with all applicable laws and regulations. ... SDS - Sunflower Lecithin Liquid Non-GMO*. (Size: 199.1 KB). * To view or ...

10.

silver-botanicals.com

silver-botanicals.com/assets/docs/MSDS-CoA/Sunflower-Lecithin-Organic-Liquid.pdf

Sunflower lecithin, organic

Safety data sheet according to. 1907/2006/EC, Article 31. Sunflower lecithin, organic. 1. Identifikation of Substance / Preparation and Company. Trade Name ...