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

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ClinicalTrials.gov Identifier: NCT02147093
Recruitment Status : Completed
First Posted : May 26, 2014
Results First Posted : July 20, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Presbyopia Correction Device: Test (multi-focal) Device: Control (Sphere) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : May 1, 2014
Actual Primary Completion Date : August 1, 2014
Actual Study Completion Date : August 1, 2014
Arms and Interventions
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Arm Intervention/treatment
Control (sphere) /Test (multi-focal)
Subjects were first fitted with Control lens (sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (multi-focal) for one week.
 Device: Test (multi-focal)
contact lens was to be worn a daily wear.
Other Names:
  • Clariti 1 Day
  • filcon II 3

Device: Control (Sphere)
contact lens was to be worn a daily wear with spectacles
Other Name: filcon II 3
Test (sphere) /Control (multi-focal)
Subjects were first fitted with the Test lens (multi-focal) for one week. Subjects were then fitted with Control lens (sphere) and a pair of reading glasses for one week.
 Device: Test (multi-focal)
contact lens was to be worn a daily wear.
Other Names:
  • Clariti 1 Day
  • filcon II 3

Device: Control (Sphere)
contact lens was to be worn a daily wear with spectacles
Other Name: filcon II 3


Outcome Measures
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Primary Outcome Measures :
  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%)


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 45 years or more
  2. Spectacle or soft contact lens wearer
  3. 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
  4. Best spectacle corrected visual acuity of 6/9 or better in each eye
  5. Willingness to adhere to the instructions set forth in the clinical protocol
  6. Signature of the subject Informed Consent form after review of Information to Participant document.

Exclusion Criteria:

  1. Systemic or ocular allergies which might interfere with contact lens wear
  2. Systemic disease which might interfere with contact lens wear
  3. Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion)
  4. Use of medication which might interfere with contact lens wear
  5. Active ocular infection
  6. Use of ocular medication
  7. Significant ocular anomaly
  8. Presence of two or more corneal scars in either eye
  9. Monovision contact lens wearers
  10. Pregnancy or lactation
  11. Any medical condition that might be prejudicial to the study
  12. Participants non-able to give consent or from a vulnerable group
  13. Infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as HIV, AIDS, etc.)
  14. Employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147093


Locations
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United Kingdom
London, United Kingdom, SW1E6AU
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
More Information
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02147093    
Other Study ID Numbers: CR-5175
First Posted: May 26, 2014    Key Record Dates
Results First Posted: July 20, 2016
Last Update Posted: June 19, 2018
Last Verified: June 2017
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases