Bioclean First Care EX / comfilcon A
OtherSubjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.
NCT Number: NCT02196766
To determine if patients are unreactive to the lens care solution / Biofinity combination.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kokama Eye Clinic, Joyo-shi, Kyoto, Japan
To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 week
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
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
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
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: Baseline
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
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).
CooperVision, Inc.
Industry
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study
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