CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation
- Conditions
- Presbyopia Correction
- Interventions
- Device: Test (multi-focal)Device: Control (Sphere)
- Registration Number
- NCT02147093
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test (sphere) /Control (multi-focal) Test (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. Control (sphere) /Test (multi-focal) Control (Sphere) 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. Test (sphere) /Control (multi-focal) Control (Sphere) 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. Control (sphere) /Test (multi-focal) 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.
- Primary Outcome Measures
Name Time Method Distance LogMAR Visual Acuity 7 days post wear 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%)
Near LogMAR Visual Acuity 7 days post wear 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%)
- Secondary Outcome Measures
Name Time Method