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

NCT ID: NCT02147093

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2014-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Test (multi-focal)

Intervention Type: DEVICE

contact lens was to be worn a daily wear.

Control (Sphere)

Intervention Type: DEVICE

contact lens was to be worn a daily wear with spectacles

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.

Group Type: OTHER

Test (multi-focal)

Intervention Type: DEVICE

contact lens was to be worn a daily wear.

Control (Sphere)

Intervention Type: DEVICE

contact lens was to be worn a daily wear with spectacles

Interventions

Test (multi-focal)

contact lens was to be worn a daily wear.

Intervention Type: DEVICE

Control (Sphere)

contact lens was to be worn a daily wear with spectacles

Intervention Type: DEVICE

Other Intervention Names

Clariti 1 Day; filcon II 3; filcon II 3

Eligibility 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)

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

CR-5175

Identifier Type: -

Identifier Source: org_study_id