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.

Study Overview

• Status: Completed
• Conditions: Presbyopia Correction
• Intervention / Treatment: Device: Test (multi-focal); Device: Control (Sphere)

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW1E6AU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: filcon II 3
Other: 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 Names: filcon II 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%)	7 days post wear
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%)	7 days post wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 26, 2014

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CR-5175