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NCT02147093

CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation

Completed NA Results posted Last updated 19 June 2018
What this trial tests

NA trial testing Test (multi-focal) in Presbyopia Correction in 41 participants. Completed in 1 August 2014.

Timeline
1 May 2014
Primary endpoint
1 August 2014
1 August 2014

Quick facts

Lead sponsorJohnson & Johnson Vision Care, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment41
Start date1 May 2014
Primary completion1 August 2014
Estimated completion1 August 2014
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

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 Acuity Primary · 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% CI
Control (Filcon II 3-sphere)-2.834± 1.0042
Test (Filcon II 3-multi-focal)-3.700± 0.8939
Near LogMAR Visual Acuity Primary · 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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.

Verify or expand the search:

Other recruiting trials for Presbyopia Correction

Currently open trials in the same condition.

Other Johnson & Johnson Vision Care, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing