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N/A N=69 Randomized Double-blind Treatment

Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently

Myopia

Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Lens Handling on Removal — 90; 95 Units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Control Lens (stenfilcon A) (Device); Test Lens (senofilcon A) (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Handling on Removal
90; 95

Summary

The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.

Eligibility Criteria

Inclusion Criteria

  • Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Self-reports having a full eye examination in the previous two years;
  • Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
  • Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wears soft contact lenses, for the past 3 months minimum;
  • No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
  • No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
  • Has refractive astigmatism no higher than -0.75DC in each eye;
  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

Exclusion Criteria

  • Is participating in any concurrent clinical or research study;
  • Has any known active ocular disease and/or infection that contraindicates contact lens wear;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
  • Has known sensitivity to the diagnostic sodium fluorescein used in the study;
  • Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Has undergone refractive error surgery or intraocular surgery.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05805150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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