EDTA Eye Drops vs. Abreva for Cold Sores

Overseen By Adrianne D Evans, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Must not be taking: Steroids, Immunosuppressants, Chemotherapy, NSAIDs

Disqualifiers: Recent outbreak, Immunosuppressed, Photosensitivity, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 7 days

20 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial requires that you stop taking any antiviral medications, steroids, immune suppressants, chemotherapeutic agents, and certain pain relievers like NSAIDs at least 30 days before joining. If you are on these medications, you will need to stop them to participate.

Is there any safety information available for EDTA Eye Drops or Abreva used in humans?

There is no specific safety information available for EDTA Eye Drops or Abreva in the provided research articles. ^{1 2 3 4 5}

How do EDTA Eye Drops and Abreva differ from other cold sore treatments?

EDTA Eye Drops and Abreva are unique in that they are being compared for treating cold sores, a condition typically treated with antiviral drugs like acyclovir. EDTA Eye Drops are not standard for cold sores, suggesting a novel approach, while Abreva is a topical cream that works by shortening healing time and duration of symptoms. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests EDTA Eye Drops and Abreva on patients with recurring cold sores. EDTA Eye Drops aim to stop the virus by reducing calcium levels, while Abreva blocks the virus from infecting skin cells. The goal is to find better treatments for cold sore outbreaks.

Research Team

Christopher M Hull, M.D.

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for adults aged 18-65 with a history of cold sores from herpes, particularly after UV exposure. They must have had at least one outbreak in the past year and know where they usually occur. Participants need to be able to follow study rules and track their pain levels. People can't join if they're immunosuppressed, recently on antivirals or steroids, pregnant, or have certain skin conditions.

Inclusion Criteria

I have had cold sores from sun exposure for at least a year.

I feel warning signs before a cold sore outbreak.

I can remember where my last or most common illness outbreak occurred.

Exclusion Criteria

Pregnant or intending to become pregnant during the study.

Enrolled in another clinical trial within the past 30 days.

You have a history of using alcohol or drugs excessively.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either EDTA Eye Drops or Abreva, applied 5 times daily for up to 7 days following UV radiation exposure

7 days

Daily self-administration, with virtual follow-ups on Days 3, 4, 5, 6, and 7

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments on Day 10 and an end of study visit

3 days

1 visit (in-person) on Day 10, 1 end of study visit

Treatment Details

Interventions

• Abreva
• EDTA Eye Drops

Trial Overview The study compares EDTA Eye Drops with Abreva in treating herpes simplex virus eruptions (cold sores). Up to 20 subjects will be randomly assigned to either treatment and will document their symptoms over a period of time using diary cards and possibly photographs.

Participant Groups

Group I: Study Drug (EDTA Eye Drops) Experimental Treatment 1 Intervention

Patients will treat herpes simplex eruption with EDTA eye drops.

Group II: Active Comparator (Abreva) Active Control 1 Intervention

Patients will treat herpes simplex eruption with Abreva.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Cyclosporine a eye drop-induced elongated eyelashes: a case report. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of nedocromil sodium 2% ophthalmic solution b.i.d. in the treatment of ragweed seasonal allergic conjunctivitis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of emedastine 0.05% or nedocromil sodium 2% eye drops and placebo in controlling local reactions in subjects with allergic conjunctivitis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of twice-daily emedastine 0.05% eye drops (Emadine eye drops) versus levocabastine 0.05% eye drops in patients with allergic conjunctivitis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Nedocromil sodium ophthalmic solution 2% twice daily in patients with allergic conjunctivitis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Ara AMP- a highly soluble new antiviral drug. [2013]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of efficacy of oral valacyclovir and topical acyclovir in the treatment of herpes simplex keratitis: a randomized clinical trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Acyclovir and vidarabine for the treatment of herpes simplex keratitis. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Assessment of acyclovir on acute ocular infection induced by drug-resistant strains of HSV-1. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Antiviral update. [2019]