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

Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

Source: ClinicalTrials.gov NCT05763628 ↗
Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Lens Handling for Removal — 94; 95 score on a scale

Summary

The objective of the study was to compare the lens performance of two daily disposable multifocal contact lenses.

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Handling for Removal
94; 95

Eligibility Criteria

Inclusion Criteria

  • Were at least 42 years of age and had full legal capacity to volunteer;
  • Had read and signed an information consent letter;
  • Self-reported having had a full eye examination in the previous two years;
  • Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week
  • Were willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wore multifocal soft contact lenses, for the past 3 months minimum
  • Maximum of 7 participants per site were habitual wearers of daily disposable lenses
  • Maximum of 3 habitual wearers per site of 1-Day Acuvue Moist Multifocal
  • Maximum of 1 habitual wearer per site of ACUVUE OASYS MAX 1-Day MULTIFOCAL
  • Maximum of 3 habitual wearers per site of MyDay Multifocal
  • Maximum of 7 participants per site were habitual wearers of frequent replacement lenses
  • Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA
  • Had refractive astigmatism no higher than -0.75DC in each eye;
  • Were presbyopic and required a reading addition of at least +0.75D and no more than +2.50D;
  • Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS, near addition as per study design)

Exclusion Criteria

A person was excluded from the study if they:

  • Were participating in any concurrent clinical or research study;
  • Had any known active ocular disease and/or infection that contraindicated contact lens wear;
  • Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
  • Were using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
  • Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
  • Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Had undergone refractive error surgery or interocular surgery.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05763628). 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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