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NCT06780306RECRUITINGIRB Ready

A Study in the Treatment of Mild to Moderate Dry Eye Disease Comparing Saline to TTAX03.

Sponsored by BioTissue Holdings, Inc

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 72 participants interested
1% interest

Express Your Interest Today

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

The purpose of this randomized, controlled, multicenter study is to evaluate the safety and efficacy of TTAX03 in participants with mild to moderate DED. The primary question it aims to answer is if TTAX03 is safe. The secondary is the effectiveness. Researchers will compare 10mg of TTAX03 reconstituted in 150, 300, or 600 uL saline to the saline control group to look at effectiveness. Participants will be randomized to a treatment group one time and be evaluated at 5 different study visits.

Who Can Participate

Inclusion Criteria

Age β‰₯ 18 years old. 2. Provision of signed and dated informed consent form. 3. Baseline VAS Dryness score β‰₯40 4. Baseline Ocular Surface Disease Index (OSDI) score β‰₯ 13. 5. Baseline corneal fluorescein staining with a total score β‰₯ 4 but ≀13, and β‰₯ 2 in at least one region, by the NEI Grading System† in the study eye. 6. In the opinion of the investigator, the participant can follow oral and written instructions. 7. In the opinion of the investigator, the participant can complete all study procedures and visits.

Exclusion Criteria

Has a corneal ectatic disorder or other ocular surface disease such as limbal stem cell deficiency or a cicatricial component (e.g., symblepharon, fornix foreshortening and lid margin/lashes abnormality) caused for example by oGVHD, irradiation, chemical burns, trachoma, Stevens Johnson syndrome/toxic epidermal necrolysis, ocular cicatricial pemphigoid, or the destruction of conjunctival goblet cells (as with vitamin A deficiency

❓ 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

72 participants

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Gender

ALL

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Sponsor

BioTissue Holdings, Inc

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Berkeley

California

Location available
View Berkeley location page
Unknown

Deerfield Beach

Florida

Location available
Unknown

Chaska

Minnesota

Location available
View Chaska location page
Unknown

Jackson

Mississippi

Location available
View Jackson location page
Unknown

Dover

New Jersey

Location available
View Dover location page
Unknown

South Orange

New Jersey

Location available
View South Orange location page
Unknown

Leland

North Carolina

Location available
View Leland location page
Unknown

Shelby

North Carolina

Location available
View Shelby location page
Unknown

Austin

Texas

Location available
View Austin location page

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

πŸ”’ Secure Β· πŸ₯ Expert Care

Looking for Dry Eye Disease Treatment in Berkeley?

Join others in California exploring innovative treatment options through clinical research

Dry Eye Disease Treatment Options in Berkeley, California

If you're searching for Dry Eye Disease treatment in Berkeley, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Berkeley, Deerfield Beach, South Dartmouth 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 California
Now Enrolling
Up to 72 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Dry Eye Disease?

Potential Benefits

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

What to Expect

  • β†’Initial screening to determine eligibility
  • β†’Regular check-ups and monitoring visits
  • β†’Possible compensation for time and travel
  • β†’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: NCT06780306. 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.