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NCT07790211 · Vance Thompson Vision

BL-RX01-TFSTAB-1402

What this study is about

A study to investigate the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®

View original scientific description

A study to investigate the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®

Interventions

DRUG

Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®

Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo® by examining potential differences in various tear film assessments before dosing Miebo® and at multiple timepoints post-Miebo® dosing

Primary outcome measures

Number of subjects with an increase from baseline of the Tear Film Index as assessed by the iTrace

Time frame: Compared from baseline to post-administration times at 5 minutes, 30 minutes, and 1 hour at both Visit One and Visit Two

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • At least 18 years of age at the time of consent
  • Able to provide written voluntary informed consent
  • Must have a normal pre-corneal tear film in one or both eyes\[MC4.1\]\[AA4.2\]
  • Subjects cannot have instilled any topical ocular drops (including OTC lubricant drops) within 24 hours of Visit 1 and Visit 2.
  • Able and willing to follow instructions, including participation in all trial assessments and visits

Exclusion criteria

  • Have any clinically significant ocular surface slit-lamp findings in either eye and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters including:
  • History of Stevens-Johnson syndrome
  • Active blepharitis or lid margin inflammation
  • DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
  • Abnormal lid anatomy causing incomplete eyelid closure
  • Abnormal cornea shape (keratoconus)
  • Corneal epithelial defect or significant confluent staining or filaments
  • History of ocular malignancy
  • Pterygium in either eye
  • Use of any of the following ocular therapies in the study eye within 24 hours prior to Visit 1 and Visit 2: Vuity®, VIZZ™, topical ocular steroid treatments, topical antibiotics, prescription dry eye therapy including varenicline nasal spray, over the counter dry eye therapy (such as artificial tears, re-wetting drops, or Lumify®), TrueTear™ device (intranasal tear neurostimulator), or topical anti-glaucoma medication
  • Have active uncontrolled ocular allergies or ocular allergies that are expected to be active during the trial period
  • Have undergone intraocular surgery or ocular laser surgery in the study eye within 3 months prior to Visit 1; have undergone refractive surgery in the study eye within 6 months prior to Visit 1
  • Have worn contact lenses within 24 hours prior to Visit 1 and Visit 2.
  • Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
  • Female subjects who are pregnant, nursing, or planning a pregnancy
  • Female subjects of childbearing potential who are not using an acceptable means of birth control; acceptable methods of contraception include hormonal (oral, implantable, injectable, or transdermal) contraception; mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom) contraception; intrauterine device; or surgical sterilization of partner. For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial
  • Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
  • Have a known allergy and/or sensitivity to the investigational product or diagnostic substances (e.g. fluorescein) to be used in the study
  • Are currently enrolled in any investigational or device study or have used Miebo® within 24 hours prior to Visit

Where

  • Sioux Falls, South Dakota

Collaborators

Bausch & Lomb Incorporated

Related conditions & keywords

Dry Eye

Frequently asked questions

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.

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.

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.

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.

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.

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.

Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations

📊
1 of 20 participants interested
5% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Sioux Falls

South Dakota

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

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

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

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

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Looking for Dry Eye Treatment in Sioux Falls?

Join others in South Dakota exploring innovative treatment options through clinical research

Dry Eye Treatment Options in Sioux Falls, South Dakota

If you're searching for Dry Eye treatment in Sioux Falls, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Sioux Falls 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. All study-related care is provided at no cost to participants.

Local Sites
1 locations in South Dakota
Now Enrolling
Up to 20 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Dry Eye?

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

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 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: NCT07790211. 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.