New imaging tools put to the test for measuring dry eye treatment effects
NCT ID NCT07722624
First seen Jul 23, 2026 · Last updated Jul 30, 2026 · Updated 3 times
Summary
This study tests whether two specialized eye imaging devices—the LipiView II and Keratograph 5M—can detect changes in tear film stability after using Miebo eye drops in people with dry eye. Twenty adults with normal tear film will have their eyes measured before and at several time points after a single dose of Miebo. The goal is to see if these devices can reliably track how the tear film responds to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Miebo (perfluorohexyloctane) eye drops
- What this could lead to
- If successful, this could improve how doctors diagnose and monitor dry eye disease by using advanced imaging to measure tear film stability.
- What could go wrong
- This is a small, early-phase study with only 20 participants, so results may not apply to all dry eye patients. The imaging devices may not detect meaningful changes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 the study visit. 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: 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. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Butchertown Clinical Trials
Louisville, Kentucky, 40206, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Temporary tear duct filling with hyaluronic acid gel and assessment of dry eye disease (DED) after bilateral cataract surgery in a prospective randomized controlled inter-eye study
- A gel plug for tear ducts may stop post-surgery dry eye
- Can a thymosin beta 4 eye drop soothe dry eye?
- Insulin-spiked eye drops may ease stubborn dry eye in Sjögren's patients
- Can four eye scanners detect how miebo stabilizes tears?
- Can a new eye scanner match the gold standard for cataract surgery?