Estudio de la solución oftálmica INV-102 en adultos con ojo seco sintomático moderado
Estudio de fase 1/2, multicéntrico, aleatorizado, con doble enmascaramiento, controlado por vehículo, de dosis ascendente múltiple (parte 1) y expansión de dosis opcional (parte 2) de la solución oftálmica INV-102 en sujetos adultos con enfermedad de ojo seco sintomático moderado
Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic dry eye disease.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
Rush, New York, Estados Unidos, 14543
- iuvo BioScience
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
- Healthy male or female subject ≥18 years of age
- Presence of moderate DED in at least one eye
Key Exclusion Criteria:
- Presently using prescription eyedrops, except those used for DED, which must be discontinued 2 weeks prior
- Use of OTC eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
- External eye disease except primary DED
- Systemic disease associated with DED
- History or evidence of ocular infection within the previous 30 days
- History or evidence of ocular herpes simplex or ocular herpes zoster
- Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: INV-102 0.1% Twice daily (BID)
Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
Experimental: INV-102 0.25% BID
Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
Experimental: INV-102 0.7% BID
Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
Experimental: INV-102 0.7% Three times daily (TID)
Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
Experimental: INV-102 TBD% BID
Part 2, Cohort 5: INV-102 ophthalmic solution administered for 2 weeks using a dose based on the results from Part 1, Cohorts 1 to 4 |
INV-102 Ophthalmic Solution |
|
Comparador de placebos: Vehicle
Part 1 (Cohorts 1-4) and Part 2 (Cohort 5): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks |
Vehicle Ophthalmic Solution |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event
Periodo de tiempo: From first dose through study completion (Day 22)
|
The primary endpoint in Part 1 of this First-in-Human (FIH) study was treatment-emergent adverse events (TEAEs) assessed across multiple dosing concentrations and dosing regimens. |
From first dose through study completion (Day 22)
|
|
Part 2: Change From Baseline to Day 15 in the Eye Dryness Score From the Dry Eye Disease (DED) Symptom Visual Analog Scale (VAS)
Periodo de tiempo: Day 15
|
The primary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Score in the study eye from the DED symptom VAS. The dry eye disease symptom visual analog scale consisted of various DED symptom parameters and was completed by subjects for each eye individually. Subjects were asked to rate their discomfort from 0 (no discomfort) to 100 (maximal discomfort) for each of the DED symptoms by placing a single vertical mark on a horizontal line based on the extent of their symptoms. |
Day 15
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 2: Change From Baseline to Day 15 in the Eye Dryness Composite Score
Periodo de tiempo: Day 15
|
The secondary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Composite Score in the study eye. The eye dryness composite score (points) combines the change from Baseline in eye dryness score from the DED symptom VAS and the change from Baseline in corneal fluorescein staining score. VAS eye dryness scores were rated by subjects on a scale of 0 (no discomfort) to 100 (maximal discomfort). Corneal fluorescein staining assessments were performed using the National Eye Institute/Industry grading scale to score each of 5 corneal zones on a 0 (no ocular surface disease) to 3 (severe ocular surface disease) scale (with a total score of 0 to 15). The calculated eye dryness composite score can range from -100 points to 100 points (positive values indicate worsening of dry eye disease signs and symptoms; negative values indicate improvement). |
Day 15
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Robert Shalwitz, MD, Invirsa, Inc.
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- INV-102-CS-001
- 75A50120C00171 (Otro número de subvención/financiamiento: ASPR-BARDA)
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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