Contact Lens Adaptation in Neophytes (CLAN)
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Has had a completed comprehensive eye exam within the past 6 months
- Able to wear spherical senofilcon A contact lenses
- Able to use Opti-Free PureMoist contact lens solution
Exclusion Criteria:
- Any prior contact lens use
- Topical eye drops within the last two hours of the study visit
- Known systemic health conditions known to alter tear film physiology
- History of severe ocular trauma
- Active ocular infection
- Active ocular inflammation
- Known hypersensitivity to diagnostic eye drops
- Pregnant or breast feeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: Full-Time Senofilcon A Contact Lens Wear
This group will start wearing contact lenses 8 or more hours per day on the first day of wear
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Otros nombres:
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Experimental: Graduated Senofilcon A Contact Lens Wear
This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours).
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)
Periodo de tiempo: 2 weeks
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This is an eye comfort survey.
The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability.
The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
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2 weeks
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart
Periodo de tiempo: 2 weeks
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The investigator will measure the subject's visual acuity with a Bailey-Lovie high-contrast paper (logMAR) chart.
logMAR is a method used to observe visual acuity.
Smaller numbers are better scores.
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2 weeks
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Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)
Periodo de tiempo: 2 Weeks
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Non-Invasive Break Up Time (NIBUT) is a measure of tear stability.
The range is 0 to 60 seconds with longer times being better tear stability.
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2 Weeks
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Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)
Periodo de tiempo: 2 Weeks
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Tear Meniscus Height (TMH) was used at a measure of tear volume.
The range is 0.0 to 2.0 mm with higher values being more tear volume.
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2 Weeks
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Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M
Periodo de tiempo: 2 Weeks
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Eye redness was measured via bulbar conjunctival redness as measured with the Keratograph 5M.
The range is 0 to 4 units with lower numbers being better.
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2 Weeks
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Between-Group Difference in Upper and Lower Eyelid Blepharitis
Periodo de tiempo: 2 Weeks
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A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis.
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2 Weeks
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Between-Group Difference in Corneal Sodium Fluorescein Staining
Periodo de tiempo: 2 Weeks
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The Brien Holden Vision Institute grading scale was used to evaluate staining by observing the eye after applying sodium fluorescein.
Scores were given for the extent (0-20 units), depth (0-20 units), type (0-20 units) of staining.
Higher scores indicate worse staining.
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2 Weeks
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Between-Group Difference in Tear Volume as Measured by Schirmer's Test I
Periodo de tiempo: 2 Weeks
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Tear volume was assessed with Schirmer's Test I test over 5 mins.
This test has a 0-35 mm range with higher values being better tear volume.
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2 Weeks
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Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)
Periodo de tiempo: 2 Weeks
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End of day contact lens comfort was measured with a visual analog scale (1-100 scale).
Higher scores indicate better comfort.
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2 Weeks
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Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores
Periodo de tiempo: 2-Weeks
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Contact lens comfort was measured with a scale (1-37 scale).
Lower scores indicate better comfort.
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2-Weeks
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Andrew D Pucker, OD, MS, Ohio State University
- Investigador principal: Jeffrey J Walline, OD, PhD, Ohio State University
Publicaciones y enlaces útiles
Publicaciones Generales
- Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.
- Sullivan BD, Crews LA, Sonmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60.
- Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.
- Yang SN, Tai YC, Sheedy JE, Kinoshita B, Lampa M, Kern JR. Comparative effect of lens care solutions on blink rate, ocular discomfort and visual performance. Ophthalmic Physiol Opt. 2012 Sep;32(5):412-20. doi: 10.1111/j.1475-1313.2012.00922.x. Epub 2012 Jul 7.
- Dougherty BE, Nichols JJ, Nichols KK. Rasch analysis of the Ocular Surface Disease Index (OSDI). Invest Ophthalmol Vis Sci. 2011 Nov 7;52(12):8630-5. doi: 10.1167/iovs.11-8027.
- Chalmers RL, Begley CG. Dryness symptoms among an unselected clinical population with and without contact lens wear. Cont Lens Anterior Eye. 2006 Mar;29(1):25-30. doi: 10.1016/j.clae.2005.12.004. Epub 2006 Jan 31.
- Faber E, Golding TR, Lowe R, Brennan NA. Effect of hydrogel lens wear on tear film stability. Optom Vis Sci. 1991 May;68(5):380-4. doi: 10.1097/00006324-199105000-00010.
- Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29.
- Pucker AD, Steele K, Rueff E, Franklin QX, McClure K, Savla K, Walline JJ. Contact Lens Adaption in Neophytes. Optom Vis Sci. 2021 Mar 1;98(3):266-271. doi: 10.1097/OPX.0000000000001662.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2014H0074
- K08EY023264 (Subvención/contrato del NIH de EE. UU.)
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