The objective of this study is to compare the short-term clinical response to all combinations of two lens types: fanfilcon A and comfilcon A with two care systems: Hy-Care and Lite. The primary variables of interest are short-term biomicroscopy signs. Other variables of interest include subjective response and visual performance.
Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
28
Hy-Care Contact Lens Solution
Lite Contact Lens Solution
fanfilcon A soft contact lens
Eurolens Research
Manchester, United Kingdom
Biomicroscopy - Conjuctival Hyperaemia
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: Baseline (before lens insertion)
Biomicroscopy - Conjuctival Hyperaemia
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: 2 hours
Biomicroscopy - Limbal Hyperaemia
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: Baseline (before contact lens insertion)
Biomicroscopy - Limbal Hyperaemia
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: 2 hours
Biomicroscopy - Corneal Vascularisation
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: Baseline (before lens insertion)
Biomicroscopy - Corneal Vascularisation
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: 2 hours
Biomicroscopy - Microcysts
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
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comfilcon A soft contact lens
Time frame: Baseline (before lens insertion)
Biomicroscopy - Microcysts
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: 2 hours
Biomicroscopy - Oedema
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: Baseline (before lens insertion)
Biomicroscopy - Oedema
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: 2 hours
Biomicroscopy - Conjunctival Staining
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: Baseline (before lens insertion)
Biomicroscopy - Conjunctival Staining
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: 2 hours
Biomicroscopy - Papillary Conjunctivitis
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: Baseline (before lens insertion)
Biomicroscopy - Papillary Conjunctivitis
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time frame: 2 hours
Comfort
Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Time frame: Baseline 5 minutes after lens insertion
Comfort
Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Time frame: 2 hours
Dryness
Subjective ratings of dryness for each pair of lenses measured only at follow up (scale: 0-100; 0=Intolerable levels of dryness, 100=No sensation of dryness).
Time frame: 2 hours
Overall Score
Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).
Time frame: Baseline 5 minutes after lens insertion
Overall Score
Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).
Time frame: 2 hours