N/A
Completed N=85
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
Presbyopia · Astigmatism
Source: ClinicalTrials.gov NCT06461455 ↗
Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses — -0.50; -0.08 logMAR
Summary
The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses |
-0.50; -0.08 | — |
Eligibility Criteria
Key Inclusion Criteria
- Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;
- Willing to not use readers while wearing study contact lenses for duration of the study;
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria
- Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Monovision contact lens wearers and wearers of contact lens in one eye only;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT06461455). 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.