Presbyopia
Conditions
Brief summary
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
Detailed description
This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.
Interventions
DEVICEComfilcon A lens (test)
contact lens
DEVICEOmafilcon B lens (control)
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
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 between ages 40-75 years, inclusive and has full legal capacity to volunteer. * Has read and understood the information consent letter. 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 of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye. * Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected. * Currently wears soft contact lenses. * Has clear corneas and no active ocular disease. * Has not worn lenses for at least 12 hours before the examination.
Exclusion criteria
A person will be excluded from the study if he/she: * 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 affect the wearing of contact lenses. * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Is aphakic. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | up to 3 hours | Visual acuity is assessed for test and control lens on a logMAR chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity | up to 3 hours | Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. |
| Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity | up to 3 hours | Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. |
| Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity | up to 3 hours | Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. |
Countries
United States
Participant flow
Pre-assignment details
Three subjects did not meet the inclusion criteria. Seventeen (17) subjects completed all visits and were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Comfilcon A Lens (Test) and Omafilcon B (Control) Subjects were randomized to wear the comfilcon A (test) or omafilcon B (control) lens for up to 3 hours, either as first or second lens during this cross over study. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Comfilcon A Lens (Test) and Omafilcon B (Control) | — |
|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 17 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Visual Acuity
Visual acuity is assessed for test and control lens on a logMAR chart
Time frame: up to 3 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A Lens (Test) | Visual Acuity | Distance: Binocular | -0.01 logMAR | Standard Deviation 0.09 |
| Comfilcon A Lens (Test) | Visual Acuity | Distance: Monocular (dominate eye) | -0.05 logMAR | Standard Deviation 0.12 |
| Comfilcon A Lens (Test) | Visual Acuity | Distant: Monocular (non-dominate eye) | 0.02 logMAR | Standard Deviation 0.13 |
| Comfilcon A Lens (Test) | Visual Acuity | Near: Binocular | 0.05 logMAR | Standard Deviation 0.09 |
| Comfilcon A Lens (Test) | Visual Acuity | Near: Monocular (dominate eye) | 0.14 logMAR | Standard Deviation 0.11 |
| Comfilcon A Lens (Test) | Visual Acuity | Near: Monocular (non-dominate eye) | 0.10 logMAR | Standard Deviation 0.13 |
| Omafilcon B Lens (Control) | Visual Acuity | Near: Monocular (dominate eye) | 0.17 logMAR | Standard Deviation 0.13 |
| Omafilcon B Lens (Control) | Visual Acuity | Distance: Binocular | -0.03 logMAR | Standard Deviation 0.16 |
| Omafilcon B Lens (Control) | Visual Acuity | Near: Binocular | 0.03 logMAR | Standard Deviation 0.07 |
| Omafilcon B Lens (Control) | Visual Acuity | Distance: Monocular (dominate eye) | 0.06 logMAR | Standard Deviation 0.21 |
| Omafilcon B Lens (Control) | Visual Acuity | Near: Monocular (non-dominate eye) | 0.04 logMAR | Standard Deviation 0.18 |
| Omafilcon B Lens (Control) | Visual Acuity | Distant: Monocular (non-dominate eye) | 0.13 logMAR | Standard Deviation 0.22 |
Secondary
Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity
Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Time frame: up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Lens (Test) | Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity | 91 units on a scale | Standard Deviation 8 |
| Omafilcon B Lens (Control) | Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity | 79 units on a scale | Standard Deviation 24 |
Secondary
Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity
Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Time frame: up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Lens (Test) | Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity | 87 units on a scale | Standard Deviation 12 |
| Omafilcon B Lens (Control) | Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity | 82 units on a scale | Standard Deviation 17 |
Secondary
Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity
Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Time frame: up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Lens (Test) | Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity | 84 units on a scale | Standard Deviation 17 |
| Omafilcon B Lens (Control) | Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity | 79 units on a scale | Standard Deviation 26 |