TFSTABEvaluation of Tear Film Stability Using TearScience™ LipiView™ II and Keratograph® 5M with Miebo®
This study aims to evaluate the impact of Miebo® on the thickness of your tear film's lipid layer, as measured by the TearScience™ LipiView™ II Ocular Surface Interferometer, to understand how it affects your tear film stability.
Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo®
Eye Diseases
+ Lacrimal Apparatus Diseases
+ Dry Eye Syndromes
Basic Science Study
Summary
Study start date: June 26, 2026
Actual date on which the first participant was enrolled.Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M 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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location