Astigmatism
Conditions
Keywords
astigmatism, orientation, visual acuity, contact lenses
Brief summary
The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.
Detailed description
Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, \ 2 hour duration.
Interventions
DEVICEsenofilcon A
toric contact lens
DEVICEbalafilcon A toric
toric contact lens
DEVICElotrafilcon B toric
toric contact lens
DEVICEomafilcon A
toric contact lens
Sponsors
Visioncare Research Ltd.
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. be at least 18 and less than or equal to 50 years of age 2. be able and willing to adhere to the instructions set forth in the protocol. 3. have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D 4. Sign the STATEMENT OF INFORMED CONSENT. 5. Have normal, healthy eyes
Exclusion criteria
1. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear. 2. Pre-existing ocular disease precluding contact lens fitting. 3. Insufficient lacrimal secretions 4. Aphakia, keratoconus or a highly irregular cornea 5. Previous eye surgery involving the anterior segment 6. Current pregnancy or lactation (to the best of the subject's knowledge). 7. Use of concurrent ocular medication 8. Active participation in another clinical study at any time during this study.-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Orientation During Head Tilt. | after fit of each of the four lens insertions | Degree of lens rotation on the eye with the head tilted. |
| Visual Acuity During Head Tilt | after each of the four lens insertions | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Lens Rotation in Superior-nasal Gaze. | After each of the four lens insertions | Degree of lens rotation while participant is gazing up and in(towards the nose). |
| Degree of Lens Rotation in Temporal Gaze. | After each of the four lens insertions | Degree of lens rotation while participant is gazing out(towards the temple). |
| Degree of Lens Rotation in Nasal Gaze. | After each of the four lens insertions | Degree of lens rotation while participant is gazing in(towards the nose). |
| Degree of Lens Rotation in Superior Gaze. | After each of the four lens insertions | Degree of lens rotation while participant is gazing up. |
| Degree of Lens Rotation in Inferior-nasal Gaze. | After each of the four lens insertions | Degree of lens rotation while participant is gazing down and in. |
| Degree of Lens Rotation in Inferior Gaze. | After each of the four lens insertions | Degree of lens rotation while participant is gazing down. |
| Degree of Lens Rotation Inferior-temporal Gaze. | After each of the four lens insertions | Degree of lens rotation while participant is gazing down and out. |
| Degree of Lens Rotation in Superior-temporal Gaze. | After each of 4 lens insertions., | Degree of lens rotation while participant is gazing up and out(towards the temple). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population Summary for overall study population | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 6 |
| Region of Enrollment United Kingdom | 14 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Lens Orientation During Head Tilt.
Degree of lens rotation on the eye with the head tilted.
Time frame: after fit of each of the four lens insertions
Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Lens Orientation During Head Tilt. | 12.2 Degree of rotation | Standard Deviation 10.7 |
| Balafilcon A Toric | Lens Orientation During Head Tilt. | 39.7 Degree of rotation | Standard Deviation 18.5 |
| Lotrafilcon B Toric | Lens Orientation During Head Tilt. | 27.6 Degree of rotation | Standard Deviation 22.7 |
| Omafilcon A Toric | Lens Orientation During Head Tilt. | 39.3 Degree of rotation | Standard Deviation 15.9 |
Comparison: Alternative Hypothesis was senofilcon A toric was superior to balafilcon A toric by having less degrees of rotationp-value: <0.0001t-test, 1 sided
Comparison: Hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having less degree of rotationp-value: 0.0002t-test, 1 sided
Comparison: Hypothesis was senofilcon A toric was superior to omafilcon A toric by having less degree of rotationp-value: <0.0001t-test, 1 sided
Primary
Visual Acuity During Head Tilt
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Time frame: after each of the four lens insertions
Population: Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Visual Acuity During Head Tilt | 0.02 logMAR units | Standard Deviation 0.06 |
| Balafilcon A Toric | Visual Acuity During Head Tilt | 0.15 logMAR units | Standard Deviation 0.2 |
| Lotrafilcon B Toric | Visual Acuity During Head Tilt | 0.07 logMAR units | Standard Deviation 0.1 |
| Omafilcon A Toric | Visual Acuity During Head Tilt | 0.11 logMAR units | Standard Deviation 0.14 |
Comparison: Alternative hypothesis was senofilcon A toric was superior to balafilcon A toric by having a lower logMAR scorep-value: 0.0083t-test, 1 sided
Comparison: Alternative hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having a lower logMAR scorep-value: 0.052t-test, 1 sided
Comparison: Alternative hypothesis was senofilcon A toric was superior to omafilcon A toric by having a lower logMAR scorep-value: 0.015t-test, 1 sided
Secondary
Degree of Lens Rotation Inferior-temporal Gaze.
Degree of lens rotation while participant is gazing down and out.
Time frame: After each of the four lens insertions
Population: Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Degree of Lens Rotation Inferior-temporal Gaze. | 3.9 Degree of rotation | Standard Deviation 3.9 |
| Balafilcon A Toric | Degree of Lens Rotation Inferior-temporal Gaze. | 5.3 Degree of rotation | Standard Deviation 4.1 |
| Lotrafilcon B Toric | Degree of Lens Rotation Inferior-temporal Gaze. | 3.7 Degree of rotation | Standard Deviation 2.8 |
| Omafilcon A Toric | Degree of Lens Rotation Inferior-temporal Gaze. | 2.5 Degree of rotation | Standard Deviation 2.3 |
p-value: 0.17t-test, 1 sided
p-value: 0.89t-test, 1 sided
p-value: 0.56t-test, 1 sided
Secondary
Degree of Lens Rotation in Inferior Gaze.
Degree of lens rotation while participant is gazing down.
Time frame: After each of the four lens insertions
Population: Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Degree of Lens Rotation in Inferior Gaze. | 3.9 Degree of rotation | Standard Deviation 4.3 |
| Balafilcon A Toric | Degree of Lens Rotation in Inferior Gaze. | 5.0 Degree of rotation | Standard Deviation 4 |
| Lotrafilcon B Toric | Degree of Lens Rotation in Inferior Gaze. | 4.2 Degree of rotation | Standard Deviation 6.3 |
| Omafilcon A Toric | Degree of Lens Rotation in Inferior Gaze. | 2.4 Degree of rotation | Standard Deviation 1.9 |
p-value: 0.27t-test, 1 sided
p-value: 0.85t-test, 1 sided
p-value: 0.73t-test, 1 sided
Secondary
Degree of Lens Rotation in Inferior-nasal Gaze.
Degree of lens rotation while participant is gazing down and in.
Time frame: After each of the four lens insertions
Population: Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Degree of Lens Rotation in Inferior-nasal Gaze. | 3.0 Degree of rotation | Standard Deviation 1.6 |
| Balafilcon A Toric | Degree of Lens Rotation in Inferior-nasal Gaze. | 9.0 Degree of rotation | Standard Deviation 6.9 |
| Lotrafilcon B Toric | Degree of Lens Rotation in Inferior-nasal Gaze. | 5.9 Degree of rotation | Standard Deviation 2.9 |
| Omafilcon A Toric | Degree of Lens Rotation in Inferior-nasal Gaze. | 9.5 Degree of rotation | Standard Deviation 5.8 |
p-value: 0.008t-test, 1 sided
p-value: 0.0049t-test, 1 sided
p-value: 0.0058t-test, 1 sided
Secondary
Degree of Lens Rotation in Nasal Gaze.
Degree of lens rotation while participant is gazing in(towards the nose).
Time frame: After each of the four lens insertions
Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Degree of Lens Rotation in Nasal Gaze. | 3.2 Degree of rotation | Standard Deviation 3.3 |
| Balafilcon A Toric | Degree of Lens Rotation in Nasal Gaze. | 7.1 Degree of rotation | Standard Deviation 5.9 |
| Lotrafilcon B Toric | Degree of Lens Rotation in Nasal Gaze. | 2.4 Degree of rotation | Standard Deviation 1.3 |
| Omafilcon A Toric | Degree of Lens Rotation in Nasal Gaze. | 3.3 Degree of rotation | Standard Deviation 3.2 |
p-value: 0.061t-test, 1 sided
p-value: 0.47t-test, 1 sided
p-value: 0.38t-test, 1 sided
Secondary
Degree of Lens Rotation in Superior Gaze.
Degree of lens rotation while participant is gazing up.
Time frame: After each of the four lens insertions
Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Degree of Lens Rotation in Superior Gaze. | 3.3 Degree of rotation | Standard Deviation 3.8 |
| Balafilcon A Toric | Degree of Lens Rotation in Superior Gaze. | 6.0 Degree of rotation | Standard Deviation 4.7 |
| Lotrafilcon B Toric | Degree of Lens Rotation in Superior Gaze. | 3.7 Degree of rotation | Standard Deviation 2.6 |
| Omafilcon A Toric | Degree of Lens Rotation in Superior Gaze. | 6.5 Degree of rotation | Standard Deviation 7 |
p-value: 0.16t-test, 1 sided
p-value: 0.73t-test, 1 sided
p-value: 0.044t-test, 1 sided
Secondary
Degree of Lens Rotation in Superior-nasal Gaze.
Degree of lens rotation while participant is gazing up and in(towards the nose).
Time frame: After each of the four lens insertions
Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Degree of Lens Rotation in Superior-nasal Gaze. | 6.2 Degree of rotation | Standard Deviation 5.4 |
| Balafilcon A Toric | Degree of Lens Rotation in Superior-nasal Gaze. | 5.6 Degree of rotation | Standard Deviation 3.6 |
| Lotrafilcon B Toric | Degree of Lens Rotation in Superior-nasal Gaze. | 6.9 Degree of rotation | Standard Deviation 4.8 |
| Omafilcon A Toric | Degree of Lens Rotation in Superior-nasal Gaze. | 5.8 Degree of rotation | Standard Deviation 4.9 |
p-value: 0.78t-test, 1 sided
p-value: 0.68t-test, 1 sided
p-value: 0.78t-test, 1 sided
Secondary
Degree of Lens Rotation in Superior-temporal Gaze.
Degree of lens rotation while participant is gazing up and out(towards the temple).
Time frame: After each of 4 lens insertions.,
Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Degree of Lens Rotation in Superior-temporal Gaze. | 6.3 Degree of rotation | Standard Deviation 5.5 |
| Balafilcon A Toric | Degree of Lens Rotation in Superior-temporal Gaze. | 9.4 Degree of rotation | Standard Deviation 5.4 |
| Lotrafilcon B Toric | Degree of Lens Rotation in Superior-temporal Gaze. | 4.9 Degree of rotation | Standard Deviation 2.3 |
| Omafilcon A Toric | Degree of Lens Rotation in Superior-temporal Gaze. | 8.6 Degree of rotation | Standard Deviation 5.8 |
p-value: 0.044t-test, 1 sided
p-value: 0.31t-test, 1 sided
p-value: 0.44t-test, 1 sided
Secondary
Degree of Lens Rotation in Temporal Gaze.
Degree of lens rotation while participant is gazing out(towards the temple).
Time frame: After each of the four lens insertions
Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Toric | Degree of Lens Rotation in Temporal Gaze. | 4.1 Degree of rotation | Standard Deviation 3.1 |
| Balafilcon A Toric | Degree of Lens Rotation in Temporal Gaze. | 7.2 Degree of rotation | Standard Deviation 5.8 |
| Lotrafilcon B Toric | Degree of Lens Rotation in Temporal Gaze. | 2.8 Degree of rotation | Standard Deviation 2.2 |
| Omafilcon A Toric | Degree of Lens Rotation in Temporal Gaze. | 6.6 Degree of rotation | Standard Deviation 5.4 |
p-value: 0.16t-test, 1 sided
p-value: 0.11t-test, 1 sided
p-value: 0.31t-test, 1 sided