Eurolens Research
Manchester, M13 9PL, United Kingdom
NCT Number: NCT03632083
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Manchester, M13 9PL, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hy-Care Contact Lens Solution
Lite Contact Lens Solution
fanfilcon A soft contact lens
comfilcon A soft contact lens
Time frame: Baseline (before lens insertion)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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 5 minutes after lens insertion
Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Time frame: 2 hours
Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Time frame: 2 hours
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: Baseline 5 minutes after lens insertion
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
Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).
CooperVision, Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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