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N/A N=66 Randomized Double-blind Treatment

Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

Myopia

Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Lens Wettability — 3.7; 3.7 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
stenfilcon A - (Test lens) (Device); kalifilcon A - (Control Lens) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Feb 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Wettability
3.5; 3.5
PRIMARY
Lens Wettability
3.5; 3.5

Summary

The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.

Eligibility Criteria

Inclusion Criteria

  • Is at least 18 years of age 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;
  • 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;
  • 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;
  • Habitually wears one of the study contact lenses;
  • 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 (NCT04668989). 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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