BL-RX01-TFSTAB-1402
Vance Thompson Vision · with Bausch & Lomb Incorporated · NCT07790211
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 4
- Target enrollment
- 20
- US sites recruiting
- 1
- Study start
- August 2026
- Record last updated
- August 27, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the 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®
Being studied: Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®
Conditions: Dry Eye
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Vance Thompson Vision
Sioux Falls, SD 57108
Site contact: Kayla Karpuk, OD · 605-361-3937 · kayla.karpuk@vancethompsonvision.com
Study contacts (from the official record)
- Kayla Karpuk, OD · 605-361-3937 · kayla.karpuk@vancethompsonvision.com
- Gabrielle Malmanger, CCRC, COA · elle.malmanger@vancethompsonvision.com
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