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OpenTrials
Completed

NCT Number: NCT02147093

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London, SW1E6AU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 45 years or more
  • Spectacle or soft contact lens wearer
  • Refraction: best sphere (corrected for back vertex distance) -6.00 Diopters (D) to +4.00 D; Astigmatism - 0.00 D to -0.75 D; Near addition for 40 cm; Medium Add: +1.50 D to +2.00 D; High Add: +2.25 D to +2.50 D
  • Best spectacle corrected visual acuity of 6/9 or better in each eye
  • Willingness to adhere to the instructions set forth in the clinical protocol
  • Signature of the subject Informed Consent form after review of Information to Participant document.

Exclusion criteria

  • Systemic or ocular allergies which might interfere with contact lens wear
  • Systemic disease which might interfere with contact lens wear
  • Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion)
  • Use of medication which might interfere with contact lens wear
  • Active ocular infection
  • Use of ocular medication
  • Significant ocular anomaly
  • Presence of two or more corneal scars in either eye
  • Monovision contact lens wearers
  • Pregnancy or lactation
  • Any medical condition that might be prejudicial to the study
  • Participants non-able to give consent or from a vulnerable group
  • Infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as HIV, AIDS, etc.)
  • Employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)

Treatment and study plan

Test (multi-focal)

Device

contact lens was to be worn a daily wear.

Other names: Clariti 1 Day, filcon II 3

Control (Sphere)

Device

contact lens was to be worn a daily wear with spectacles

Other names: filcon II 3

Primary outcomes

  1. Distance LogMAR Visual Acuity

    Time frame: 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%)

  2. Near LogMAR Visual Acuity

    Time frame: 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%)

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 26, 2014
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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