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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Presbyopia Correction

Treatments: Device: Test (multi-focal); Device: Control (Sphere)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02147093

CR-5175

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Control (sphere) /Test (multi-focal)

Other group

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.

Treatment:

Device: Control (Sphere)

Device: Test (multi-focal)

Test (sphere) /Control (multi-focal)

Other group

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.

Treatment:

Device: Control (Sphere)

Device: Test (multi-focal)