Mode
Text Size
Log in / Sign up
N/A Completed N=63 Single-blind Treatment

Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design

Source: ClinicalTrials.gov NCT04952701 ↗
Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: Comfort on Insertion — 9.2; 9.2 units on a scale

Summary

The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.

Outcome Measures

OutcomeResultp-value
PRIMARY
Comfort on Insertion
9.2; 9.2

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 (powers +4.00 to -6.00DS)

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 (NCT04952701). 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.

Back to search