N/A
Completed N=63
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
| Outcome | Result | p-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.
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.