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

NCT02147093 | Completed Results

• 1 other identifier: CR-5175
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia Correction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control (sphere) /Test (multi-focal)

OTHER

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); Device: Control (Sphere)

Test (sphere) /Control (multi-focal)

OTHER

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); Device: Control (Sphere)

Interventions

Test (multi-focal) DEVICE

contact lens was to be worn a daily wear.

Also known as: Clariti 1 Day, filcon II 3

Control (sphere) /Test (multi-focal); Test (sphere) /Control (multi-focal)

Control (Sphere) DEVICE

contact lens was to be worn a daily wear with spectacles

Also known as: filcon II 3

Control (sphere) /Test (multi-focal); Test (sphere) /Control (multi-focal)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Unknown Facility

London, SW1E6AU, United Kingdom

Location

Results Point of Contact

• Title: Tom Karkkainen, OD, MS, FAAO
• Organization: Johnson & Johnson Vision Care INC.

TKarkkai@its.jnj.com

904-443-3500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 26, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 19, 2018
• Results First Posted: July 20, 2016

Record last verified: 2017-06

Locations

GB (1)