Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
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|ClinicalTrials.gov Identifier: NCT00708032|
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : December 8, 2011
Last Update Posted : May 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Refractive Error Myopia||Device: spectacles Device: narafilcon A soft contact lenses||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
habitual spectacles worn daily for 12 months
Experimental: narafilcon A soft contact lenses
narafilcon A soft contact lenses worn as daily disposable for 12 months
Device: narafilcon A soft contact lenses
narafilcon A daily disposable contact lenses
- Papillary Conjunctivitis [ Time Frame: 12 months ]Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.
- Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. [ Time Frame: at 12 months ]Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.
- Visual Acuity After 12 Months of Wear [ Time Frame: at 12 months ]Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.
- Subjective Overall Comfort After 12 Months of Daily Wear [ Time Frame: at 12 months ]subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort
- Subjective Overall Vision After 12 Months of Daily Wear [ Time Frame: at 12 months ]subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708032
|Eurolens Research, The University of Manchester|
|Manchester, Greater Manchester, United Kingdom, M60 1QD|