N/A
N=9
Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
Refractive Errors · Presbyopia · Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT05886907 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Mean Distance Visual Acuity (VA) With Study Lenses — -0.04; -0.09 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lehfilcon A multifocal toric contact lenses (Device); Samfilcon A multifocal toric contact lenses (Device); CLEAR CARE (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Distance Visual Acuity (VA) With Study Lenses |
-0.04; -0.09 | — |
Summary
The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.
Eligibility Criteria
Key Inclusion Criteria
- Requires ADD (additional power for near vision);
- Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
- Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
- Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria
- Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
- Monovision contact lens wear.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05886907). 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.