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NCT07025811RECRUITINGIRB Ready

A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment

Sponsored by Hoffmann-La Roche

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (Vevye® or Xiidra®), in participants with dry eye disease (DED) compared to healthy volunteers (control participants).

Who Can Participate

Inclusion Criteria

A. Inclusion Criteria for Participants with DED:
The participant reported dry eye-related ocular symptoms for at least 6 months before the screening visit
The participant must have either used lubricant eye drops regularly OR had the desire to use lubricant eye drops in the past 3 months
Participant must be classified as having moderate/severe DED
The participant is deemed by the physician to require a prescription medication for DED (e.g., cyclosporin A or lifitegrast) B. Inclusion Criteria for Healthy Volunteers: \- The participant does not have overt clinical signs of DED in either eye

Exclusion Criteria

Intraocular pressure (IOP) \>21.00 millimeters of mercury (mmHg) in either eye
Acute allergic conjunctivitis in either eye within 3 months prior to screening
Use of contact lenses within 30 days prior to screening
Current punctal plugs or punctal cauterization or occlusion
Use of ocular anti-inflammatory agents or ocular immunosuppressive

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

350 participants

Gender

ALL

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Sponsor

Hoffmann-La Roche

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Louisville

Kentucky

Location available
RECRUITING

Andover

Massachusetts

Location available
RECRUITING

Garner

North Carolina

Location available
RECRUITING

Memphis

Tennessee

Location available
ACTIVE_NOT_RECRUITING

Lynchburg

Virginia

Location available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

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Looking for Dry Eye Disease Treatment in Louisville?

Join others in Kentucky exploring innovative treatment options through clinical research

Dry Eye Disease Treatment Options in Louisville, Kentucky

If you're searching for Dry Eye Disease treatment in Louisville, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Louisville, Memphis, Lynchburg and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Dry Eye Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Kentucky
Now Enrolling
Up to 350 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Dry Eye Disease?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Dry Eye Disease

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Dry Eye Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07025811. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.