Dry EyePhase 4NCT07790211
BL-RX01-TFSTAB-1402
A Phase 4 study testing Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo® in people with Dry Eye, run by Vance Thompson Vision at 1 site in United States.
Trial summary
A study to investigate the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo® Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gabrielle Malmanger, CCRC, COA contact
United States1 site, 1 recruiting
- Recruiting
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Kayla Karpuk, OD, 605-361-3937, kayla.karpuk@vancethompsonvision.com
About this study
Official title: A Single Center, Open-Label Study to Evaluate the Ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to Detect Tear Film Stability Utilizing Miebo®
A study to investigate the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®
- Conditions
- Dry Eye
- Being tested
- Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Determine ability of iTrace™ BOSA™ OPD-Scan III & IDRA to detect tear film stability utilizing Miebo | Experimental | Miebo administered once in each eye on Visit One and Visit Two Receives: Drug: Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with an increase from baseline of the Tear Film Index as assessed by the iTrace
Measured: Compared from baseline to post-administration times at 5 minutes, 30 minutes, and 1 hour at both Visit One and Visit Two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790211
- Sponsor's protocol ID
- BL-RX01-TFSTAB-1402
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-Label Study to Evaluate the Ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to Detect Tear Film Stability Utilizing Miebo®
- ClinicalTrials.gov ID
- NCT07790211
- Acronym / sponsor ID
- BL-RX01-TFSTAB-1402
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to investigate the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Determine ability of iTrace™ BOSA™ OPD-Scan III & IDRA to detect tear film stability utilizing Miebo | Experimental | Drug: Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®Miebo administered once in each eye on Visit One and Visit Two |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Determine ability of iTrace™ BOSA™ OPD-Scan III & IDRA to detect tear film stability utilizing Miebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabrielle Malmanger, CCRC, COA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo® in people with Dry Eye, run by Vance Thompson Vision at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Karpuk, OD (605-361-3937, kayla.karpuk@vancethompsonvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.