To determine if patients are unreactive to the lens care solution / Biofinity combination.
To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
30
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.
Kokama Eye Clinic
Joyo-shi, Kyoto, Japan
Higashihara Clinic
Kameoka, Kyoto, Japan
Dougenzaka Ioti Eye Clinic
Shibuya-ku, Tokyo-to, Japan
Ocular Health - Corneal Staining
Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time frame: 1 week
Ocular Health - Conjunctival Redness
Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time frame: 1 week
Ocular Health - Limbal Redness
Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time frame: 1 week
Ocular Health - Papillary Conjunctivitis
Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time frame: 1 week
Stinging Sensation Right After Insertion (Subjective Rating)
Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Time frame: Baseline
Burning Sensation Right After Insertion (Subjective Rating)
Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Time frame: Baseline
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