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N/A N=40 Single-blind Treatment

Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

Myopia · Hyperopia

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Lens Fit Acceptance Rating — 3.28; 3.48 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lens A (Device); Lens B (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Oct 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Fit Acceptance Rating
3.28; 3.48

Summary

This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

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, 5 days a week.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
  • Has refractive astigmatism no higher than -0.75DC.
  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)

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 (NCT05656885). 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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