Evaluation of an Investigational Multifocal Lens
18 de junio de 2018 actualizado por: Johnson & Johnson Vision Care, Inc.
The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
371
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Alabama
-
Montgomery, Alabama, Estados Unidos, 36109
-
-
California
-
Mission Viejo, California, Estados Unidos, 92691
-
-
Florida
-
Jacksonville, Florida, Estados Unidos, 32205
-
Jacksonville, Florida, Estados Unidos, 32250
-
Orange Park, Florida, Estados Unidos, 32065
-
Saint Augustine, Florida, Estados Unidos, 32092
-
Tallahassee, Florida, Estados Unidos, 32308
-
Tampa, Florida, Estados Unidos, 33625
-
Winter Park, Florida, Estados Unidos, 32792
-
-
Georgia
-
Roswell, Georgia, Estados Unidos, 30076
-
-
Kansas
-
Pittsburg, Kansas, Estados Unidos, 66762
-
-
Michigan
-
East Lansing, Michigan, Estados Unidos, 48823
-
-
New York
-
Vestal, New York, Estados Unidos, 13850
-
-
North Carolina
-
Denver, North Carolina, Estados Unidos, 28037
-
-
Ohio
-
Powell, Ohio, Estados Unidos, 43065
-
Springfield, Ohio, Estados Unidos, 45503
-
-
Rhode Island
-
Warwick, Rhode Island, Estados Unidos, 02888
-
-
Tennessee
-
Memphis, Tennessee, Estados Unidos, 38119
-
-
Texas
-
Tyler, Texas, Estados Unidos, 75701
-
-
Virginia
-
Salem, Virginia, Estados Unidos, 24153
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- The subjects were required to have read, understand, and signed the Statement of Informed Consent and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Between 40 and 70 years of age.
- Subjects must own a wearable pair of spectacles, if required for their distance vision.
- Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration)
- Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire"*
- The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
- Refractive cylinder ≤ -0.75 D in each eye.
- ADD power in the range +0.75 D to +2.50 D in each eye.
- Best corrected visual acuity of 20/20-3 or better in each eye.
Exclusion Criteria:
- Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
- Any ocular or systemic allergies that may have contraindicated contact lens wear.
- Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
- Any ocular abnormality that may have interfered with contact lens wear.
- Use of any ocular medication, with the exception of rewetting drops.
- Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- History of herpetic keratitis.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
- History of diabetes.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
- Any ocular infection or inflammation.
- Any corneal distortion or irregular cornea.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: lotrafilcon B / etafilcon A
Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
|
Soft contact lens to be worn as daily wear, monthly replacement modality.
Otros nombres:
Soft contact lens to be worn as daily wear, daily disposable modality.
|
|
Experimental: etafilcon A / lotrafilcon B
Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.
|
Soft contact lens to be worn as daily wear, monthly replacement modality.
Otros nombres:
Soft contact lens to be worn as daily wear, daily disposable modality.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
Periodo de tiempo: 8 -12 days post wear
|
CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire.
CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
97% of the scores fall within 0 and 120 (mean +/-3XSD).
|
8 -12 days post wear
|
|
Distance Binocular Visual Acuity (LogMAR)
Periodo de tiempo: 8- 12 Days post wear
|
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
|
8- 12 Days post wear
|
|
Intermediate Binocular Visual Acuity (LogMAR)
Periodo de tiempo: 8-12 days post wear
|
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
|
8-12 days post wear
|
|
Near Binocular Visual Acuity (LogMAR)
Periodo de tiempo: 8-12 days post wear
|
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
|
8-12 days post wear
|
|
Corneal Staining
Periodo de tiempo: 8 - 12 Days post wear
|
Corneal staining is evaluated using Sodium Fluorescein strips.
The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva.
The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.),
Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.).
The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
|
8 - 12 Days post wear
|
|
Bulbar Conjunctival Injection
Periodo de tiempo: 8- 12 Days post wear
|
The bulbar is the scelra.
Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments.
Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe.
The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
|
8- 12 Days post wear
|
|
Limbal Conjunctival Injection
Periodo de tiempo: 8- 12 Days post wear
|
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera.
Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments.
Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe.
The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
|
8- 12 Days post wear
|
|
Contact Lens Fitting
Periodo de tiempo: 8- 12 Days post wear
|
Contact Lens fitting is reported as a binary response.
Yes- acceptable lens fit, No- unacceptable lens fit.
The percentage of subject eyes with acceptable fit is reported.
|
8- 12 Days post wear
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2014
Finalización primaria (Actual)
1 de noviembre de 2014
Finalización del estudio (Actual)
1 de noviembre de 2014
Fechas de registro del estudio
Enviado por primera vez
20 de agosto de 2014
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2014
Publicado por primera vez (Estimar)
22 de agosto de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de junio de 2018
Última verificación
1 de julio de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR-5593
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .