Presbyopia Correction
Conditions
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.
Interventions
DEVICETest (multi-focal)
contact lens was to be worn a daily wear.
DEVICEControl (Sphere)
contact lens was to be worn a daily wear with spectacles
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%) |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 41 subjects were enrolled in this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 40 subjects were dispensed a study lens. Of the dispensed subjects, 3 were discontinued and 37 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal) All subjects that were randomized to sequence and were dispensed a study lens. | 20 |
| Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher) All subjects that were randomized to sequence and were dispensed a study lens. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Lost to Follow-up | 0 | 1 |
| Period 2 | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal) | Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher) | Total |
|---|---|---|---|
| Age, Continuous | 56.20 years STANDARD_DEVIATION 7.682 | 58.00 years STANDARD_DEVIATION 9.067 | 56.78 years STANDARD_DEVIATION 8.49 |
| Region of Enrollment United Kingdom | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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%)
Time frame: 7 days post wear
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (Filcon II 3-sphere) | Distance LogMAR Visual Acuity | High Contrast-Distance-Standard High Luminance | -0.466 LogMAR | Standard Deviation 0.9995 |
| Control (Filcon II 3-sphere) | Distance LogMAR Visual Acuity | Low Contrast-Distance-Standard High Luminance | -2.842 LogMAR | Standard Deviation 1.685 |
| Control (Filcon II 3-sphere) | Distance LogMAR Visual Acuity | High Contrast-Distance-Standard Low Luminance | -2.834 LogMAR | Standard Deviation 1.0042 |
| Test (Filcon II 3-multi-focal) | Distance LogMAR Visual Acuity | High Contrast-Distance-Standard High Luminance | -0.972 LogMAR | Standard Deviation 1.0104 |
| Test (Filcon II 3-multi-focal) | Distance LogMAR Visual Acuity | Low Contrast-Distance-Standard High Luminance | -3.768 LogMAR | Standard Deviation 1.8023 |
| Test (Filcon II 3-multi-focal) | Distance LogMAR Visual Acuity | High Contrast-Distance-Standard Low Luminance | -3.700 LogMAR | Standard Deviation 0.8939 |
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%)
Time frame: 7 days post wear
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (Filcon II 3-sphere) | Near LogMAR Visual Acuity | High Contrast-Near-Standard High Luminance | -1.455 LogMAR | Standard Deviation 0.6309 |
| Control (Filcon II 3-sphere) | Near LogMAR Visual Acuity | Low Contrast-Near-Standard High Luminance | -2.151 LogMAR | Standard Deviation 1.0221 |
| Control (Filcon II 3-sphere) | Near LogMAR Visual Acuity | High Contrast-Near-Standard Low Luminance | -1.878 LogMAR | Standard Deviation 1.0546 |
| Test (Filcon II 3-multi-focal) | Near LogMAR Visual Acuity | High Contrast-Near-Standard High Luminance | -2.545 LogMAR | Standard Deviation 1.124 |
| Test (Filcon II 3-multi-focal) | Near LogMAR Visual Acuity | Low Contrast-Near-Standard High Luminance | -3.820 LogMAR | Standard Deviation 1.4124 |
| Test (Filcon II 3-multi-focal) | Near LogMAR Visual Acuity | High Contrast-Near-Standard Low Luminance | -3.441 LogMAR | Standard Deviation 1.3941 |