Back to resultsCLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation
Primary Purpose
Presbyopia Correction
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Test (multi-focal)
Control (Sphere)
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia Correction
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control (sphere) /Test (multi-focal)
Test (sphere) /Control (multi-focal)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Distance LogMAR Visual Acuity
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%)
Near LogMAR Visual Acuity
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%)
Secondary Outcome Measures
Full Information
NCT ID
NCT02147093
First Posted
May 21, 2014
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02147093
Brief Title
CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (Actual)
Primary Completion Date
August 1, 2014 (Actual)
Study Completion Date
August 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia Correction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control (sphere) /Test (multi-focal)
Arm Type
Other
Arm Description
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.
Arm Title
Test (sphere) /Control (multi-focal)
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Test (multi-focal)
Other Intervention Name(s)
Clariti 1 Day, filcon II 3
Intervention Description
contact lens was to be worn a daily wear.
Intervention Type
Device
Intervention Name(s)
Control (Sphere)
Other Intervention Name(s)
filcon II 3
Intervention Description
contact lens was to be worn a daily wear with spectacles
Primary Outcome Measure Information:
Title
Distance LogMAR Visual Acuity
Description
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%)
Time Frame
7 days post wear
Title
Near LogMAR Visual Acuity
Description
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%)
Time Frame
7 days post wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
City
London
ZIP/Postal Code
SW1E6AU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation
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