ClinicalTrials.gg
RecruitingNCT07790211Updated Aug 27, 2026

BL-RX01-TFSTAB-1402

A Phase 4 interventional study of Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo® in Dry Eye, sponsored by Vance Thompson Vision. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Vance Thompson Vision · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Dry Eye

Browse trials for

03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Have any 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:

    1. History of Stevens-Johnson syndrome
    2. Active blepharitis or lid margin inflammation
    3. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
    4. Abnormal lid anatomy causing incomplete eyelid closure
    5. Abnormal cornea shape (keratoconus)
    6. Corneal epithelial defect or significant confluent staining or filaments
    7. History of ocular
  2. Pterygium in either eye
  3. 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 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
  4. Have active uncontrolled ocular allergies or ocular allergies that are expected to be active during the trial period
  5. 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
  6. Have worn contact lenses within 24 hours prior to Visit 1 and Visit 2.
  7. Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
  8. Female subjects who are pregnant, nursing, or planning a pregnancy
  9. Female subjects of who are not using an acceptable means of ; 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
  10. Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
  11. Have a known allergy and/or sensitivity to the product or diagnostic substances (e.g. fluorescein) to be used in the study
  12. Are currently enrolled in any investigational or device study or have used Miebo® within 24 hours prior to Visit
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Determine ability of iTrace™ BOSA™ OPD-Scan III & IDRA to detect tear film stability utilizing Miebo

    Miebo administered once in each eye on Visit One and Visit Two

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

Interventions

  • DrugDetermine 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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07790211
Lead sponsor
Vance Thompson Vision
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Aug 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Aug 27, 2026

Study contacts

Kayla Karpuk, OD
Contact
kayla.karpuk@vancethompsonvision.com
605-361-3937
Gabrielle Malmanger, CCRC, COA
Contact
elle.malmanger@vancethompsonvision.com

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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