What side effects are associated with this type of intervention?

Common treatments for Dry Eye Syndrome include artificial tears, topical glucocorticoids, cyclosporine eye drops, and omega-3 fatty acid supplements. Artificial tears generally have minimal side effects but can cause temporary blurred vision or mild irritation. Topical glucocorticoids, while effective, can lead to increased intraocular pressure, cataract formation, and glaucoma if used long-term. Cyclosporine eye drops may cause burning sensations upon application. Omega-3 fatty acid supplements are generally well-tolerated but can interact with blood-thinning medications and cause gastrointestinal discomfort. Hydration and nutrient support, similar to the Dry Eye Drink, typically have fewer side effects, primarily limited to mild gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Dry Eye Syndrome, including topical cyclosporine (Restasis) and lifitegrast (Xiidra), which are aimed at reducing inflammation and increasing tear production. Additionally, varenicline nasal spray has been approved to stimulate tear production. While specific hydration and nutrient support treatments like the Dry Eye Drink are not mentioned, the general approach of using artificial tears and supplements to maintain eye moisture and health is well-established in the management of Dry Eye Syndrome.

What other types of research exist?

Promising novel alternatives to the Dry Eye Drink for Dry Eye Syndrome patients in 2024 include: 1) Sodium hyaluronate-based artificial tears, which have shown superiority in improving ocular staining and symptoms. 2) Autologous serum tears, which may improve symptoms though access and cost can be barriers. 3) Tear stimulation agents, including systemic pilocarpine and other emerging topical agents. 4) Oral antioxidants, which have shown efficacy in small trials. These options should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Dry Eye Drink for Dry Eye Syndrome

N/A

Waitlist Available

Research Sponsored by Bruder Healthcare

Eligibility Criteria Checklist

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

Must have

Male and/or female subjects aged between 18 and 65 years (both limits inclusive)

Subjects with symptomatic Dry Eye Syndrome confirmed at baseline in at least any one or both the eyes

Must not have

Have evidence of clinically significant ocular trauma

Have active ocular Herpes simplex or Herpes Zoster infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 and day 30

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drink called the Dry Eye Drink to see if it helps people with dry eyes. Participants will mix a powder with water and drink it. The goal is to find out if better hydration can make their eyes feel less dry.

Who is the study for?

This trial is for men and women aged 18-65 with Dry Eye Syndrome, confirmed by specific tests (MMP-9 and tear osmolarity) and a self-reported questionnaire. Participants must be able to give consent and follow the study plan. Pregnant or nursing individuals, recent eye surgery patients, those with ocular infections or unstable systemic diseases, participants in other studies within the last month, illiterate individuals who can't keep a diary, people allergic to drink ingredients or with certain eyelid/ocular conditions are excluded.

What is being tested?

The study is testing the 'Dry Eye Drink' on its ability to hydrate and improve symptoms of dryness in eyes affected by Dry Eye Syndrome. It's an observational study where subjects consume the drink and report changes in their condition.

What are the potential side effects?

While not explicitly stated here, potential side effects may include discomfort from taste or gastrointestinal issues due to new dietary components introduced by the 'Dry Eye Drink'.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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I have been diagnosed with Dry Eye Syndrome in at least one eye.

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My test for MMP-9 was positive.

Exclusion Criteria

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

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I have had a serious eye injury.

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I currently have an active eye infection caused by herpes.

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I have an eye infection.

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I have severe eyelid inflammation.

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I have a significant eyelid condition affecting its function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 and day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 and day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 and day 30 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change on the SPEED score

Secondary study objectives

Change in MMP-9 levels

Change in Tear Osmolarity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dry Eye DrinkExperimental Treatment1 Intervention

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 Dry Eye Syndrome include hydration and nutrient support, artificial tears, anti-inflammatory medications, and secretagogues. Hydration and nutrient support, such as the Dry Eye Drink, aim to improve overall hydration and provide essential nutrients that support tear production and ocular surface health. Artificial tears help to lubricate the eyes and maintain tear film stability. Anti-inflammatory medications, like cyclosporine drops, reduce inflammation on the ocular surface, which can improve tear production and reduce symptoms. Secretagogues, such as varenicline nasal spray, stimulate the glands to produce more tears. These treatments are crucial for Dry Eye Syndrome patients as they address the underlying issues of tear production and ocular surface health, providing symptomatic relief and preventing further complications.