Tratamiento con Lipiflow solo frente a tratamiento con Lipiflow + Dextenza para la enfermedad del ojo seco
Dexametasona intracanalicular utilizada junto con LipiFlow para el tratamiento de la disfunción de las glándulas de Meibomio en pacientes con enfermedad del ojo seco por evaporación y evidencia de inflamación clínicamente significativa
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation compared to LipiFlow Thermal Pulsation alone. In addition, this study will evaluate the ease of Dextenza insertion and the patient preference for therapy.
After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye), while the other eye will be assigned to a receive a sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Per patient, the study period will last for approximately 12 weeks after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3 post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12, primary and secondary endpoints will be assessed alongside standard-of-care procedures. Adjusting for enrollment period, the study will last a total of approximately 4 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46040
- Eye Surgeons of Indiana
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- 18 years of age or older
- Evaporative DED with MGD and clinically significant inflammation
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
- Patients under the age of 18.
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Altered nasolacrimal flow of either acquired, induced, or congenital origin
- Hypersensitivity to dexamethasone
- Patient being treated with either topical, oral, or intravenous steroids
- Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Lipiflow Only Group
Patients with dry eye disease Lipiflow only |
To manage patients with dry eye disease secondary to MGD |
|
Experimental: Lipiflow + Dextenza Group
Patients with dry eye disease Lipiflow + Dextenza |
to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Meibomian Gland Scores (Expressibility and Quality)
Periodo de tiempo: Assessed at Baseline, Week 1, Week 4 and Week 12
|
Meibomian gland expressibility was graded at the slit lamp using the methodology of the pivotal LipiFlow trial. Fifteen glands of the lower eyelid (5 temporal, 5 central, 5 nasal) were each graded on a 0-3 scale (0 = no secretion; 1 = inspissated/toothpaste-like secretion; 2 = cloudy liquid secretion; 3 = clear liquid secretion). Grades were summed to produce a composite Meibomian Gland Expressibility Score ranging from 0 to 45. Higher scores indicate better meibomian gland function. Values shown are the mean score at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12
|
|
Patient Preference
Periodo de tiempo: Assessed at Week 12
|
As measured by COMTOL Survey |
Assessed at Week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Rate of Positive MMP-9
Periodo de tiempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Meibomian gland inflammation was assessed using the InflammaDry point-of-care immunoassay, which detects elevated matrix metalloproteinase-9 (MMP-9) levels in tear fluid. Results are reported as positive or negative based on a predefined assay threshold. The outcome represents the proportion of eyes testing positive for MMP-9 at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
|
Mean Change in Ocular Surface Staining
Periodo de tiempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Corneal fluorescein staining was graded on a 0-3 scale (none to heavy) in 5 corneal regions (superior, inferior, nasal, temporal, central) and summed for a corneal score (range 0-15). Conjunctival lissamine green staining was graded on the same 0-3 scale in 6 conjunctival regions (3 nasal, 3 temporal) and summed for a conjunctival score (range 0-18). Corneal and conjunctival scores were summed to produce a total Ocular Surface Staining Score ranging from 0 to 33. Higher scores indicate greater ocular surface damage (worse outcome). Values shown are the mean score at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
|
Mean Change in Tear Break-up Time (TBUT)
Periodo de tiempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Tear break-up time (TBUT) was measured in seconds following fluorescein instillation as the interval between a complete blink and the first appearance of tear film disruption. Higher TBUT values indicate greater tear film stability. Values shown are the mean TBUT at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
|
Mean Change in Tear Osmolarity (mOsm/L)
Periodo de tiempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Tear osmolarity was measured using a point-of-care tear osmolarity system and reported in milliosmoles per liter (mOsm/L). Higher values indicate greater tear film hyperosmolarity and ocular surface stress. Values shown are the mean tear osmolarity at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
|
Mean Change in DEQ-5
Periodo de tiempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Dry eye symptoms were assessed using the Dry Eye Questionnaire-5 (DEQ-5), a validated patient-reported outcome instrument with scores ranging from 0 to 22. Higher DEQ-5 scores indicate greater severity of dry eye symptoms. The outcome represents the mean change in DEQ-5 score from baseline at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
|
Mean Change in Best-corrected Visual Acuity (BCVA)
Periodo de tiempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Best-corrected visual acuity (BCVA) was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and recorded as the number of letters read correctly (range 0 to 100 letters). Higher letter scores indicate better visual acuity. Values shown are the mean BCVA letter score at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Damon Dierker, OD, FAAO, Eye Surgeons of Indiana
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de los ojos
- Enfermedades del aparato lagrimal
- Síndromes del ojo seco
- Compuestos de azufre
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Derivados de benceno
- Ácidos sulfónicos
- Ácidos de azufre
- Bencenosulfonatos
- Arilsulfonatos
- Ácidos arilsulfónicos
- Dobesilato de calcio
Otros números de identificación del estudio
- The DIERKER Study
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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