University of Waterloo
Waterloo, Ontario, N2L 3G1, Canada
NCT Number: NCT04492397
The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each
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Notify Me17 year and older
All sexes
Interventional
Not applicable
Waterloo, Ontario, N2L 3G1, Canada
The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates the study test lens and control lens.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be randomized to wear test lenses.
Other names: stenfilcon A
Subjects will be randomized to wear control lenses.
Other names: verofilcon A
Time frame: 1 week
Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)
Time frame: Baseline
Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
Time frame: 1 week
Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
Time frame: Baseline
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Time frame: 1 week
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Time frame: Baseline
Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Time frame: 1 week
Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)
CooperVision, 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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