N/A
Completed N=60
Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types
Source: ClinicalTrials.gov NCT06232590 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Lens Handling for Insertion — 95; 96 score on a scale
Summary
To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Handling for Insertion |
95; 96 | — |
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 spherical multifocal soft contact lenses, for the past 3 months minimum:
- Maximum of 4 participants (out of 12) per site could be habitual wearers of daily disposable lenses,
- Maximum of 4 participants (out of 12) per site could be habitual wearers of Biofinity Multifocal,
- Maximum of 4 participants (out of 12) per site could be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
- Had 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;
- Could be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).
Exclusion Criteria
- 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 or ocular 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 affect contact lens wear or a study outcome variable;
- Had known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Had undergone refractive error surgery or intraocular surgery.
Data sourced from ClinicalTrials.gov (NCT06232590). 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.