What side effects are associated with this type of intervention?

Common treatments for contact lens complications similar to HydroEye® include dietary supplements containing omega-3 and omega-6 fatty acids (EPA, DHA, GLA, ALA) and vitamins. Known side effects of these supplements can include gastrointestinal issues such as nausea, diarrhea, and indigestion. High doses of omega-3 fatty acids may also increase the risk of bleeding and interact with anticoagulant medications. Additionally, some individuals may experience allergic reactions to specific components in the supplements.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for dietary supplements like HydroEye® for the treatment of contact lens complications. However, treatments for related conditions such as dry eye disease include various formulations of omega-3 fatty acids and other supplements aimed at improving ocular surface health. For instance, omega-3 supplements have been studied for their potential benefits in reducing inflammation and improving tear film stability, which can alleviate symptoms of dry eye and related discomfort. While HydroEye® itself has not been assessed for contact lens discomfort, its components are similar to those used in other treatments aimed at improving eye health.

What other types of research exist?

Promising alternatives to HydroEye® for contact lens discomfort include: 1) Omega-3 fatty acid supplements, which have shown benefits in reducing dry eye symptoms and inflammation. 2) Gamma-linolenic acid (GLA) supplements, which have demonstrated efficacy in modulating inflammatory responses. 3) Probiotics, which may improve gut microbiome health and indirectly benefit eye health. 4) Melatonin, which has shown potential in reducing inflammation and improving sleep, thereby potentially alleviating eye discomfort. Patients should consult with their healthcare provider to determine the most appropriate treatment.

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PUFAs and Antioxidants

HydroEye® Supplement for Contact Lens Discomfort

Phase 4

Waitlist Available

Led By Andrew D Pucker, OD, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye

Increased severity of dry eye symptoms with contact lens wear by at least 25% as determined by patient self-report

Must not have

Have temporary and/or permanent punctal plugs inserted

Any previous corneal surgery, including all types of corneorefractive surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up mean change at 6 months.

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests HydroEye®, a supplement with fish oils and vitamins, to see if it helps people who have discomfort from wearing contact lenses by improving eye health.

Who is the study for?

Adults over 18 who wear soft contact lenses daily for at least 6 hours, have dry eye symptoms worsened by lens use, and can follow the study protocol. Participants must not have severe eyelid issues or a history of corneal surgery, take certain medications like anticoagulants regularly, eat lots of fatty fish weekly, or be pregnant.

What is being tested?

The trial is testing HydroEye®, a dietary supplement with omega fatty acids and antioxidants (vitamins A, E, C), to see if it helps people who experience discomfort from wearing contact lenses due to dry eyes.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include reactions related to ingredients in HydroEye® such as fish oil or vitamins. Allergies or intolerance to these components should be considered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can see clearly with contact lenses, at least 20/30 vision in both eyes.

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My dry eye symptoms worsen by 25% or more when I wear contact lenses.

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I experience significant dry eye symptoms from wearing contact lenses.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have punctal plugs inserted in my tear ducts.

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I have had surgery on my eye's cornea before.

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I have used blood thinners, aspirin, NSAIDs, or steroids recently, or I bruise easily.

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I have no major eye surface issues causing discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mean change at 6 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mean change at 6 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and mean change at 6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Contact Lens Dry Eye Questionnaire (CLDEQ-4)

Secondary study objectives

Conjunctival Staining

Corneal Staining

Neuropathic Pain Symptom Inventory (NPSI) Questionnaire

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HydroEye®Experimental Treatment1 Intervention

Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).

Group II: PlaceboPlacebo Group1 Intervention

Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for contact lens complications, such as the dietary supplement HydroEye®, work by leveraging the anti-inflammatory and tear film-stabilizing properties of omega-3 and omega-6 fatty acids (EPA, DHA, GLA, ALA) along with essential vitamins. These components help reduce inflammation, enhance tear production, and improve the lipid layer of the tear film, which is crucial for maintaining eye moisture and comfort. For contact lens wearers, this means reduced eye discomfort, better hydration, and overall improved eye health, making it easier to wear lenses for extended periods.

Effects of altering the eicosanoid precursor pool on neovascularization and inflammation in the alkali-burned rabbit cornea.Essential fatty acids for dry eye: A review.