TFSTABEvaluación de la estabilidad de la película lagrimal utilizando TearScience™ LipiView™ II y Keratograph® 5M con Miebo®
Este estudio tiene como objetivo evaluar el impacto de Miebo® en el espesor de la capa lipídica de su película lagrimal, medido por el interferómetro de superficie ocular TearScience™ LipiView™ II, para comprender cómo afecta a la estabilidad de su película lagrimal.
Determine the ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to detect tear film stability utilizing Miebo®
Enfermedades Oculares
+ Enfermedades del aparato lagrimal
+ Síndromes de ojo seco
Estudio de Ciencia Básica
Resumen
Fecha de inicio: 26 de junio de 2026
Fecha en la que se inscribió al primer participante.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
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 20 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Ciencia Básica
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Butchertown Clinical Trials
Louisville, United StatesAbrir Butchertown Clinical Trials en Google Maps