45 and older, any sex, with Presbyopia Correction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Distance LogMAR Visual AcuityPrimary· 7 days post wear
Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m\^2 and 2.5 cd/m\^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m\^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (2.5 cd/m\^2) High Contrast (90%)
High Contrast-Distance-Standard High Luminance
Group
Value
95% CI
Control (Filcon II 3-sphere)
-0.466
± 0.9995
Test (Filcon II 3-multi-focal)
-0.972
± 1.0104
Low Contrast-Distance-Standard High Luminance
Group
Value
95% CI
Control (Filcon II 3-sphere)
-2.842
± 1.6850
Test (Filcon II 3-multi-focal)
-3.768
± 1.8023
High Contrast-Distance-Standard Low Luminance
Group
Value
95% CI
Control (Filcon II 3-sphere)
-2.834
± 1.0042
Test (Filcon II 3-multi-focal)
-3.700
± 0.8939
Near LogMAR Visual AcuityPrimary· 7 days post wear
Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m\^2 and 50 cd/m\^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m\^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (50cd/m\^2) High Contrast (90%)
High Contrast-Near-Standard High Luminance
Group
Value
95% CI
Control (Filcon II 3-sphere)
-1.455
± 0.6309
Test (Filcon II 3-multi-focal)
-2.545
± 1.1240
Low Contrast-Near-Standard High Luminance
Group
Value
95% CI
Control (Filcon II 3-sphere)
-2.151
± 1.0221
Test (Filcon II 3-multi-focal)
-3.820
± 1.4124
High Contrast-Near-Standard Low Luminance
Group
Value
95% CI
Control (Filcon II 3-sphere)
-1.878
± 1.0546
Test (Filcon II 3-multi-focal)
-3.441
± 1.3941
Sponsor's own description
A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Vision Care, Inc.
Last refreshed: 19 June 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02147093.