This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
51
senofilcon A contact lenses with 8.5 base curve
senofilcon A contact lenses with 9.0 base curve
narafilcon A contact lenses with 8.5 base curve
Aston University Optometry and Vision Science
Birmingham, United Kingdom
Visioncare Research
Farnham, United Kingdom
Overall Fit Acceptance
Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.
Time frame: 30-45 minutes after lens settling
Lens Power Requirement
The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control).
Time frame: 30-45 minutes after lens settling
Subjective Comfort at Lens Insertion
Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.
Time frame: Immediately upon lens insertion
Subjective Comfort After Lens Settling
Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.
Time frame: 30-45 minutes after lens settling
Subjective Vision Quality
Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported.
Time frame: 30-45 minutes after lens settling
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narafilcon A contact lenses with 9.0 base curve
Subjective Handling
Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported.
Time frame: Immediately upon lens insertion
Monocular High Contrast Visual Acuity (VA)
Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.
Time frame: 30-45 minutes after lens settling