Astigmatism, Presbyopia
Conditions
Brief summary
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
Detailed description
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
Interventions
contact lens
DEVICEomafilcon A Multifocal Toric Lens
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has had a self-reported oculo-visual examination in the last two years. * Is aged 40-75 years, inclusive and has full legal capacity to volunteer. * Has read and understood the participant information sheet. * Is willing and able to follow instructions and maintain the appointment schedule. * Is able to participate in Parts A and B related to this work. * Has a contact lens spherical prescription between +10.00 to -10.00D (inclusive). * Has an Add component to their spectacle refraction (between +0.75 and +2.50DS). * Has astigmatism between -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye. * Can be satisfactorily fitted with the study lenses. * Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected. * They have successfully worn soft contact lenses in the last six months * Has clear corneas and no active ocular disease. * Has not worn lenses for at least 12 hours before the examination. * Has an up-to-date pair of spectacles.
Exclusion criteria
* Has never worn contact lenses before. * Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that will affect ocular health. * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses. * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study. * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Is aphakic. * Has undergone corneal refractive surgery. * Has a history of anaphylaxis or severe allergic reaction. * Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator. * They are pregnant or breast-feeding. * Is participating in any other type of eye-related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Up to 2 hours | Visual Acuity (measured in LogMAR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity | Up to 2 hours | Subjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. |
| Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity | Up to 2 hours | Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. |
| Assessment of Visual Performance: Near Task for Vision Quality and Clarity | Up to 2 hours | Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. |
Countries
United Kingdom
Participant flow
Pre-assignment details
Three subjects did not meet the inclusion criteria. Ten (10) subjects completed all visits and their data were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Comfilcon A and Omafilcon A Multifocal Toric Lenses Subjects were randomized to wear the comfilcon A multifocal toric (test) or omafilcon A multifocal toric (control) lens, either as first or second lens during this cross over study. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Comfilcon A and Omafilcon A Multifocal Toric Lenses | — |
|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 10 participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Visual Acuity
Visual Acuity (measured in LogMAR)
Time frame: Up to 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Multifocal Toric Lens | Visual Acuity | Distance: Binocular | -0.08 logMAR | Standard Deviation 0.05 |
| Test Multifocal Toric Lens | Visual Acuity | Distance: Monocular (dominate eye) | 0.00 logMAR | Standard Deviation 0.09 |
| Test Multifocal Toric Lens | Visual Acuity | Distant: Monocular (non-dominate eye) | 0.02 logMAR | Standard Deviation 0.09 |
| Test Multifocal Toric Lens | Visual Acuity | Near: Binocular | 0.10 logMAR | Standard Deviation 0.12 |
| Test Multifocal Toric Lens | Visual Acuity | Near: Monocular (dominate eye) | 0.15 logMAR | Standard Deviation 0.17 |
| Test Multifocal Toric Lens | Visual Acuity | Near: Monocular (non-dominate eye) | 0.17 logMAR | Standard Deviation 0.15 |
| Control Multifocal Toric Lens | Visual Acuity | Near: Monocular (dominate eye) | 0.16 logMAR | Standard Deviation 0.17 |
| Control Multifocal Toric Lens | Visual Acuity | Distance: Binocular | -0.06 logMAR | Standard Deviation 0.1 |
| Control Multifocal Toric Lens | Visual Acuity | Near: Binocular | 0.06 logMAR | Standard Deviation 0.12 |
| Control Multifocal Toric Lens | Visual Acuity | Distance: Monocular (dominate eye) | -0.01 logMAR | Standard Deviation 0.06 |
| Control Multifocal Toric Lens | Visual Acuity | Near: Monocular (non-dominate eye) | 0.12 logMAR | Standard Deviation 0.14 |
| Control Multifocal Toric Lens | Visual Acuity | Distant: Monocular (non-dominate eye) | 0.01 logMAR | Standard Deviation 0.1 |
Secondary
Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity
Subjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Time frame: Up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Multifocal Toric Lens | Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity | 93 units on a scale | Standard Deviation 9 |
| Control Multifocal Toric Lens | Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity | 87 units on a scale | Standard Deviation 16 |
Secondary
Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity
Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Time frame: Up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Multifocal Toric Lens | Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity | 95 units on a scale | Standard Deviation 9 |
| Control Multifocal Toric Lens | Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity | 95 units on a scale | Standard Deviation 9 |
Secondary
Assessment of Visual Performance: Near Task for Vision Quality and Clarity
Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Time frame: Up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Multifocal Toric Lens | Assessment of Visual Performance: Near Task for Vision Quality and Clarity | 94 units on a scale | Standard Deviation 8 |
| Control Multifocal Toric Lens | Assessment of Visual Performance: Near Task for Vision Quality and Clarity | 90 units on a scale | Standard Deviation 20 |