N/A
Completed N=59
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
| Outcome | Result | p-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.
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.