Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Multicenter Dispensing Study of Biofinity Lenses in Extended Range

8 de noviembre de 2017 actualizado por: CooperVision, Inc.
To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

19

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

  • Canadá
    • Ontario
      • Waterloo, Ontario, Canadá, N2L 3G1
        • CCLR, University of Waterloo
  • Estados Unidos
    • California
      • Berkeley, California, Estados Unidos, 94720-2020
        • UC Berkeley Clinica Research Center
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46266-6057
        • CORL, Indiana University School of Optometry
    • Texas
      • Houston, Texas, Estados Unidos, 77204-2020
        • TERTC, University of Houston

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Has had an oculo-visual examination in the last two years
  • Is at least 18 years of age and has full legal capacity to volunteer
  • Has read and understood the information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their habitual vision correction
  • Currently wears soft contact lenses
  • They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
  • Has clear corneas and no active ocular disease
  • Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria:

  • Has any systemic disease affecting ocular health
  • Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
  • Have any active ocular disease and/or infection that would contraindicate contact lens wear.
  • Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
  • Has worn gas permeable contact lenses within the last month.
  • Is aphakic
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of clinical research study
  • Female who is currently pregnant or is breast-feeding.

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Biofinity XR
Participants dispensed Biofinity XR lenses over two weeks of lens wear
Dispositivo: Biofinity XR

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dryness (During Day and Dryness at Night)
Periodo de tiempo: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.
Baseline
Dryness (During Day)
Periodo de tiempo: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Dryness (During Day and Dryness at Night)
Periodo de tiempo: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.
2 Weeks
Comfort (Insertion, End of Day, Overall)
Periodo de tiempo: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Baseline
Comfort (Insertion)
Periodo de tiempo: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Comfort (Insertion, End of Day, Overall)
Periodo de tiempo: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
2 Weeks
Ghosting (Multiple Images)
Periodo de tiempo: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.
Baseline
Ghosting (Multiple Images)
Periodo de tiempo: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Ghosting (Multiple Images)
Periodo de tiempo: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.
2 Weeks
Hazing (Blurred Edges)
Periodo de tiempo: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.
Baseline
Hazing (Blurred Edges)
Periodo de tiempo: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.
2 Weeks
Vision Quality (During Day and at Night)
Periodo de tiempo: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.
Baseline
Vision Quality (During Day)
Periodo de tiempo: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Vision Quality (During Day and at Night)
Periodo de tiempo: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.
2 Weeks
Handling (Insertion, Removal, Overall)
Periodo de tiempo: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Baseline
Handling (Insertion, Removal, Overall)
Periodo de tiempo: 2 weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
2 weeks
Overall Satisfaction of Comfort, Vision, Handling
Periodo de tiempo: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Overall Satisfaction of Comfort, Vision, Handling
Periodo de tiempo: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.
Baseline
Overall Satisfaction of Comfort, Vision, Handling
Periodo de tiempo: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.
2 Weeks
Comfort Preference
Periodo de tiempo: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Comfort Preference
Periodo de tiempo: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
2 Weeks
Vision Preference
Periodo de tiempo: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Vision Preference
Periodo de tiempo: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
2 Weeks
Handling Preference
Periodo de tiempo: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
2 Weeks
Overall Preference
Periodo de tiempo: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Overall Preference
Periodo de tiempo: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
2 Weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Lens Centration - Habitual Lenses
Periodo de tiempo: Baseline
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.
Baseline
Lens Centration
Periodo de tiempo: Dispense
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.
Dispense
Lens Centration
Periodo de tiempo: 2 Weeks
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.
2 Weeks
Lens Movement - Habitual Lenses
Periodo de tiempo: Baseline
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.
Baseline
Lens Movement
Periodo de tiempo: Dispense
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Lens Movement
Periodo de tiempo: 2 Weeks
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.
2 Weeks
Overall Fit Acceptance
Periodo de tiempo: Baseline
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.
Baseline
Overall Fit Acceptance
Periodo de tiempo: Dispense
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Overall Fit Acceptance
Periodo de tiempo: 2 Weeks
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.
2 Weeks
Visual Acuity
Periodo de tiempo: Baseline
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.
Baseline
Visual Acuity
Periodo de tiempo: Dispense
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Visual Acuity
Periodo de tiempo: 2 Weeks
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.
2 Weeks
Anterior Ocular Physiological Response
Periodo de tiempo: Baseline
Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.
Baseline
Anterior Ocular Physiological Response
Periodo de tiempo: 2 Weeks
Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.
2 Weeks
Average Wearing Time
Periodo de tiempo: Baseline
Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline.
Baseline
Average Wearing Time
Periodo de tiempo: 2 Weeks
Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks.
2 Weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

CooperVision, Inc.

Investigadores

  • Investigador principal: Lyndon Jones, CCLR, University of Waterloo
  • Investigador principal: Meng Lin, CRC, University of California Berkeley
  • Investigador principal: Jan Bergmanson, TERTC, University of Houston
  • Investigador principal: Pete Kollbaum, CORL, Indiana University

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 octubre de 2013

Finalización primaria (Actual)

1 de abril de 2014

Finalización del estudio (Actual)

1 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

6 de febrero de 2014

Primero enviado que cumplió con los criterios de control de calidad

10 de febrero de 2014

Publicado por primera vez (Estimar)

12 de febrero de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de diciembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

8 de noviembre de 2017

Última verificación

1 de junio de 2015

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CV-13-47

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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. .

Suscribir