Biofinity soft contact lens
DeviceBiofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
NCT Number: NCT02354924
The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens could be prescribed as a supportive care for myopic persons.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
This randomized controlled study will involve at least 50 evaluable subjects divided evenly among 5 study sites in Taiwan. Each study site will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. Subjects who have normal ocular health and conform to a set of standard criteria will wear one of the study lenses on two eyes and follow up for 3 months (90 days). Lenses will be assigned to subject according to a predetermined randomized order. It is necessary to remove contact lenses every day and replace after 30 days. Any unscheduled visit will be allowed when there is a medication necessary. The data for slit lamp findings, symptoms/problems/complaints, keratometry (K) reading, refractive changes (absolute value), visual acuity data, average wear time (AWT), discontinuations, and lens replacement will be collected to claim that the VISCO Soft Contact Lens is as safe and effective as BIOFINITY (comfilcon A) Soft Contact Lens (CooperVision).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
Time frame: 3 months
Visual acuity correctable to snellen 20/25 or better
Time frame: 3 month
Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings
Time frame: 3 month
Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye
Visco Vision Inc.
Industry
A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of VISCO Soft Contact Lens on a Daily Wear Basis
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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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