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N/A Completed N=41 Single-blind Treatment

Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design

Source: ClinicalTrials.gov NCT05516082 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Lens Fit Acceptance — 3.51; 3.68 score on a scale

Summary

This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Fit Acceptance
3.51; 3.68

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 the required time of the study.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Has refractive astigmatism no higher than -0.75 DC.
  • Can be fit with the available lens parameters (sphere +8.00 to -10.00D).
  • Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

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 (NCT05516082). 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. Informational only — not medical advice.

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