Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
Contact lens
Contact lens
Clinical Research Center, University of California, Berkeley
Berkeley, California, United States
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, United States
Lens Surface Wettability
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time frame: Baseline
Lens Surface Wettability
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time frame: 2-weeks
Lens Surface Wettability
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time frame: 4-weeks
Lens Surface Deposits
Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time frame: Baseline
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Lens Surface Deposits
Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface).
Time frame: 2-weeks
Lens Surface Deposits
Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time frame: 4-weeks
Overall Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time frame: Baseline
Overall Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time frame: 2-Weeks
Overall Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time frame: 4-Weeks
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Time frame: Baseline
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Time frame: 2-weeks
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Time frame: 4-weeks
Bulbar Conjunctiva Hyperaemia
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: Baseline
Bulbar Conjunctiva Hyperaemia
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: 2-weeks
Bulbar Conjunctiva Hyperaemia
Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: 4-weeks
Limbal Conjunctiva Hyperaemia
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: Baseline
Limbal Conjunctiva Hyperaemia
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: 2-weeks
Limbal Conjunctiva Hyperaemia
Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time frame: 4-weeks