galyfilcon A prototype lens
Devicesilicone hydrogel contact lens
NCT Number: NCT01180985
The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.
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Notify Me18 year–39 year
All sexes
Interventional
Not applicable
Jacksonville, Florida, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
silicone hydrogel contact lens
silicone hydrogel contact lens
Other names: Biofinity® contact lens
Time frame: after 7 +/- 1 days of lens wear
Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.
Time frame: after 7 +/- 1 days of lens wear
Snellen binocular visual acuity measurement
Time frame: after 7 +/-1 days of lens wear
The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time frame: after 7 +/- 1 days of lens wear
Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time frame: after 7 days of lens wear
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time frame: after 7 days of lens wear
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time frame: 10 minutes after lens insertion at time of initial lens fitting
Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Johnson & Johnson Vision Care, Inc.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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