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

Presbyopia Correction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147093
• Other study ID #: CR-5175
• Status: Completed
• Phase: N/A
• Start date: May 1, 2014
• Est. completion date: August 1, 2014

Study information

• Verified date: June 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 1, 2014
• Est. primary completion date: August 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Presbyopia
• Presbyopia Correction

Intervention

Device:
• Test (multi-focal)
contact lens was to be worn a daily wear.
• Control (Sphere)
contact lens was to be worn a daily wear with spectacles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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