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N/A Completed N=59 Randomized Single-blind Treatment

Comparing the Performance of 1 Day Multifocal Contact Lenses

Source: ClinicalTrials.gov NCT04449263 ↗
Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Subjective At-home Ratings for Ease of Lens Handling for Insertion — 8.90; 8.28; 9.18 units on a scale

Summary

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective At-home Ratings for Ease of Lens Handling for Insertion
8.90; 8.28; 9.18

Eligibility Criteria

Inclusion Criteria

  • Is at least 42 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;
  • Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
  • Has refractive astigmatism no higher than -0.75DC;
  • Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
  • 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 (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).

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 (NCT04449263). 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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