Electrostimulation for Dry Eye Syndrome

Overseen By Michael Cheung, MSc, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zhonghui K. Luo, MD, PhD

Must not be taking: Cytotoxic agents, Gabapentin

Disqualifiers: Pregnancy, Contact lens, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether electrostimulation, a therapy using electrical currents, can help individuals with dry eye issues caused by ocular Graft vs. Host Disease. Participants will wear electrodes on their cheeks and forehead. Some will receive the actual treatment, while others will receive a placebo (inactive treatment) for comparison. It suits those with a chronic diagnosis of ocular Graft vs. Host Disease and noticeable eye discomfort in daily life. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain drugs like Gabapentin or if your immunosuppression regimen changes within a month of starting the study or during the study.

What prior data suggests that this electrostimulation is safe for treating ocular Graft vs. Host Disease?

Research has shown that electrostimulation is usually well-tolerated in similar treatments. Some studies have examined its use for dry eye disease and have not identified major safety issues. Although specific side effects are not detailed in the sources, ongoing research suggests it remains reasonably safe. Notably, electrostimulation is also under study for other conditions, indicating its potential safety. However, potential participants should consult their doctors to understand any personal health considerations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about electrostimulation for dry eye syndrome because it offers a novel approach by using gentle electrical currents to stimulate nerves around the eyes. Unlike the standard treatments like artificial tears, anti-inflammatory drops, or punctal plugs, which focus on adding moisture or reducing inflammation, electrostimulation aims to enhance the body’s natural tear production by activating nerve pathways. This method could potentially offer a more sustainable and natural way to alleviate symptoms, providing relief for patients who may not respond well to existing treatments.

What evidence suggests that electrostimulation is effective for ocular Graft vs. Host Disease?

Research has shown that electrical stimulation can help alleviate dry eye symptoms. In this trial, participants will join different groups to assess the effectiveness of electrostimulation. One study found that transcutaneous electrical nerve stimulation (TENS) improved these symptoms. Additionally, a review of studies provided promising evidence that a similar technique, neurostimulation, can effectively treat dry eye disease. These treatments appear to work by stimulating nerves that aid in tear production, relieving dryness. Overall, evidence suggests that electrical stimulation could benefit those with dry eye conditions. ^{1 3 4 5 6}

Who Is on the Research Team?

Zhonghui Luo, MD, PhD

Principal Investigator

Massachusetts Eye and Ear Infirmary

Are You a Good Fit for This Trial?

This trial is for individuals with chronic ocular Graft vs. Host Disease, evidenced by an OSDI score of 22+ and NEI corneal staining score of 2+. Participants must not have pacemakers, be pregnant, wear contact lenses, have open eyelid wounds or active eye diseases. Recent surgery recipients and those on certain medications are also excluded.

Inclusion Criteria

OSDI score of 22 or higher

NEI corneal staining score (or modified NEI score) of 2 or higher

I have been diagnosed with chronic eye problems due to graft vs. host disease.

Exclusion Criteria

Patients with a pacemaker or ICD

Patients currently pregnant or with a potential to be pregnant during the study

Patients who wear contact lens of any kind

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous electrical stimulation (TES) or sham treatment for 30 minutes per session over a course of 10 treatments

8 weeks

10 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

• Electrostimulation

Trial Overview The study is examining the effectiveness of electrostimulation treatment (ET) in treating dry eye syndrome caused by ocular Graft vs. Host Disease. It involves using electrodes with and without currents to see if there's a difference in outcomes between the two methods.

How Is the Trial Designed?

Group I: Electrostimulation Experimental Treatment 1 Intervention

The experimental group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITH amplitude.

Group II: Sham Placebo Group 1 Intervention

The placebo group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITHOUT amplitude.

Who Is Running the Clinical Trial?

Zhonghui K. Luo, MD, PhD

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12109051/

Evaluating Magnetic Stimulation as an Innovative Approach ... Our findings indicate that RMS is a safe and well-tolerated modality, resulting in the significant amelioration of dry eye symptoms, as ...

2. link.springer.com link.springer.com/article/10.1007/s40123-022-00616-6

Effectiveness of Intranasal Tear Neurostimulation for ... This meta-analysis provides promising evidence for the controversial effectiveness of intranasal tear neurostimulation in the treatment of dry eye disease.

3. researchgate.net researchgate.net/publication/346151072_Effectiveness_of_transcutaneous_electrical_stimulation_combined_with_artificial_tears_for_the_treatment_of_dry_eye_A_randomized_controlled_trial

(PDF) Effectiveness of transcutaneous electrical stimulation ... Discussion Our data indicate that TENS may similarly provide analgesia in patients with dry eye symptoms as it does for many other chronic pain ...

4. medrxiv.org medrxiv.org/content/10.1101/2024.03.27.24304988v1.full-text

Evaluating Magnetic Stimulation as an Innovative ... A study that investigated the use of transcutaneous electrical nerve stimulation (TENS) [32] found that this treatment improved symptoms of dry ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0928098722000914

Current trends in pharmaceutical treatment of dry eye ... This review highlights the etiologies, the pathophysiology of DED, and the role of diagnostic techniques in the policy of treatment.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05203796?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(%22Keratoconjunctivitis%22)%20AND%20SEARCH%5BLocation%5D(AREA%5BLocationCountry%5DKorea,%20Republic%20of)))&rank=9

The Evaluation of the Transcutaneous Electrical ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...