Tear-Fluid Stability Testing with iTrace, BOSA, OPD-Scan III, and IDRA for Dry Eye

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 4 trial will evaluate if the iTrace, BOSA, OPD-Scan III, and IDRA instruments can detect tear film stability when used with Miebo®. Eligible participants are adults with normal pre-corneal tear film who are able to consent and adhere to study visits. Participants will undergo assessments at Visit 1 and Visit 2, with no topical ocular drops within 24 hours of each visit. The study is sponsored by Vance Thompson Vision with Bausch & Lomb as a collaborator and will be conducted at a Vance Thompson Vision site in Sioux Falls, SD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least 18 years of age at the time of consent
2. Able to provide written voluntary informed consent
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:

1. 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:

   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 malignancy
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 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
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 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
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 investigational 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

Where it's running

• Vance Thompson Vision
  Sioux Falls, South Dakota, United States Recruiting

Study contacts

• Study coordinator: Kayla Karpuk, OD
• Email: kayla.karpuk@vancethompsonvision.com
• Phone: 605-361-3937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.