A Single Center, Open-Label Study to Evaluate the Ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to Detect Tear Film Stability Utilizing Miebo®

Running, not enrolling · Phase 4

Conditions studied: Dry Eye

In brief

A study to investigate the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo®

Key facts

Study ID

NCT07722624

Run by

The Eye Care Institute

People needed

20

Starts

2026-06-26

Expected to finish

2026-08-30

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 the study visit.
• Able and willing to follow instructions, including participation in all trial assessments and visits

You may not qualify if…

• 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: 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.
• 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

Where it is running

• Butchertown Clinical Trials — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.