Presbyopia
Conditions
Brief summary
The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
Detailed description
This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.
Interventions
contact lens
DEVICEcomfilcon A control lens
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
A person is eligible for inclusion in the study if he/she: * Has had a self-reported oculo-visual examination in the last two years * Is 50 years of age or greater and has full legal capacity to volunteer * Is able to read and understand the informed consent * Is willing and able to follow instructions and maintain the appointment schedule * Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive) * Near Add Power requirement of +2.25D or greater * Has spectacle cylinder 0.75 D in both eyes * Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D) * Has monocular best-corrected distance visual acuity of 20/30 or better in each eye * Has clear corneas and no active ocular disease * Has not worn gas permeable contact lenses for 1 month prior to the study
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 abnormality that would affect the wearing of contact lenses * Is aphakic (i.e. missing their natural lens inside their eye) * Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D * 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 | 4 days | Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR. |
| Visual Performance | 4 days | Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Handling | 4 Days | Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle). |
| Average Daily Wearing Time | 4 days | Average daily wearing time for test and control lens is assessed in hours. |
| Lens Fit | 4 days | Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit. |
| Bulbar Hyperemia | 4 days | Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. |
| Subjective Satisfaction | 4 days | Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied) |
| Limbal Hyperemia | 4 days | Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. |
| Subjective Ratings for Comfort | Baseline | Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). |
| Subjective Preference for Distance Vision | 4 days | Subjective preference for distance vision for test and control contact lenses. |
| Subjective Preference for Intermediate Vision | 4 days | Subjective preference for intermediate vision for test and control contact lenses. |
| Subjective Preference for Overall Vision | 4 days | Subjective preference for overall vision for test and control contact lenses. |
| Subjective Preference for Comfort | 4 days | Subjective preference for comfort for test and control contact lenses. |
| Subjective Overall Lens Preference | 4 days | Subjective overall lens preference for test and control contact lenses. |
| Subjective Preference for Near Vision | 4 days | Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction. |
| Subjective Ratings for Dryness | Baseline | Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects will be randomized to wear the test contact lenses or control contact lenses first as per the randomization table bilaterally for four days then cross-over to alternated pair lenses.
comfilcon A Extended Range test lens: contact lenses comfilcon A control lens: contact lenses | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 14 Participants | — |
| Age, Continuous | 57 years STANDARD_DEVIATION 7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 14 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Visual Acuity
Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR.
Time frame: 4 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Visual Acuity | Intermediate | -0.15 LogMAR | Standard Deviation 0.16 |
| Comfilcon A Extended Range Test Lens | Visual Acuity | Near | -0.02 LogMAR | Standard Deviation 0.09 |
| Comfilcon A Extended Range Test Lens | Visual Acuity | Distance | -0.01 LogMAR | Standard Deviation 0.09 |
| Comfilcon A Control Lens | Visual Acuity | Intermediate | -0.13 LogMAR | Standard Deviation 0.1 |
| Comfilcon A Control Lens | Visual Acuity | Distance | -0.07 LogMAR | Standard Deviation 0.1 |
| Comfilcon A Control Lens | Visual Acuity | Near | 0.01 LogMAR | Standard Deviation 0.07 |
Primary
Visual Performance
Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).
Time frame: 4 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Visual Performance | Distance | 72 units on a scale | Standard Deviation 19 |
| Comfilcon A Extended Range Test Lens | Visual Performance | Intermediate | 85 units on a scale | Standard Deviation 17 |
| Comfilcon A Extended Range Test Lens | Visual Performance | Near | 79 units on a scale | Standard Deviation 23 |
| Comfilcon A Control Lens | Visual Performance | Distance | 77 units on a scale | Standard Deviation 20 |
| Comfilcon A Control Lens | Visual Performance | Intermediate | 88 units on a scale | Standard Deviation 13 |
| Comfilcon A Control Lens | Visual Performance | Near | 80 units on a scale | Standard Deviation 16 |
Secondary
Average Daily Wearing Time
Average daily wearing time for test and control lens is assessed in hours.
Time frame: 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Average Daily Wearing Time | 10 Hours/day | Standard Deviation 2 |
| Comfilcon A Control Lens | Average Daily Wearing Time | 9 Hours/day | Standard Deviation 3 |
Secondary
Bulbar Hyperemia
Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Time frame: 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Bulbar Hyperemia | 0.88 units on a scale | Standard Deviation 0.44 |
| Comfilcon A Control Lens | Bulbar Hyperemia | 0.89 units on a scale | Standard Deviation 0.42 |
Secondary
Lens Fit
Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit.
Time frame: 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Lens Fit | 3.3 units on a scale | Standard Deviation 0.4 |
| Comfilcon A Control Lens | Lens Fit | 3.3 units on a scale | Standard Deviation 0.3 |
Secondary
Lens Handling
Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle).
Time frame: 4 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Lens Handling | 89 units on a scale | Standard Deviation 25 |
| Comfilcon A Control Lens | Lens Handling | 95 units on a scale | Standard Deviation 9 |
Secondary
Limbal Hyperemia
Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Time frame: 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Limbal Hyperemia | 0.13 units on a scale | Standard Deviation 0.26 |
| Comfilcon A Control Lens | Limbal Hyperemia | 0.18 units on a scale | Standard Deviation 0.28 |
Secondary
Subjective Overall Lens Preference
Subjective overall lens preference for test and control contact lenses.
Time frame: 4 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Overall Lens Preference | Test | 4 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Overall Lens Preference | No Preference | 0 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Overall Lens Preference | Control | 9 Participants |
Secondary
Subjective Preference for Comfort
Subjective preference for comfort for test and control contact lenses.
Time frame: 4 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Preference for Comfort | Test | 4 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Preference for Comfort | No Preference | 3 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Preference for Comfort | Control | 6 Participants |
Secondary
Subjective Preference for Distance Vision
Subjective preference for distance vision for test and control contact lenses.
Time frame: 4 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Preference for Distance Vision | Test | 3 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Preference for Distance Vision | No Preference | 2 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Preference for Distance Vision | Control | 8 Participants |
Secondary
Subjective Preference for Intermediate Vision
Subjective preference for intermediate vision for test and control contact lenses.
Time frame: 4 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Preference for Intermediate Vision | Test | 3 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Preference for Intermediate Vision | No Preference | 4 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Preference for Intermediate Vision | Control | 6 Participants |
Secondary
Subjective Preference for Near Vision
Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction.
Time frame: 4 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Preference for Near Vision | Test | 4 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Preference for Near Vision | No Preference | 4 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Preference for Near Vision | Control | 5 Participants |
Secondary
Subjective Preference for Overall Vision
Subjective preference for overall vision for test and control contact lenses.
Time frame: 4 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Preference for Overall Vision | Test | 3 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Preference for Overall Vision | No Preference | 1 Participants |
| Comfilcon A Extended Range Test Lens | Subjective Preference for Overall Vision | Control | 9 Participants |
Secondary
Subjective Ratings for Comfort
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Ratings for Comfort | 96 units on a scale | Standard Deviation 8 |
| Comfilcon A Control Lens | Subjective Ratings for Comfort | 91 units on a scale | Standard Deviation 6 |
Secondary
Subjective Ratings for Comfort
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Time frame: 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Ratings for Comfort | 87 units on a scale | Standard Deviation 21 |
| Comfilcon A Control Lens | Subjective Ratings for Comfort | 89 units on a scale | Standard Deviation 17 |
Secondary
Subjective Ratings for Dryness
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Time frame: 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Ratings for Dryness | 83 units on a scale | Standard Deviation 23 |
| Comfilcon A Control Lens | Subjective Ratings for Dryness | 88 units on a scale | Standard Deviation 14 |
Secondary
Subjective Ratings for Dryness
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Ratings for Dryness | 94 units on a scale | Standard Deviation 9 |
| Comfilcon A Control Lens | Subjective Ratings for Dryness | 94 units on a scale | Standard Deviation 7 |
Secondary
Subjective Satisfaction
Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied)
Time frame: 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Extended Range Test Lens | Subjective Satisfaction | 71 units on a scale | Standard Deviation 23 |
| Comfilcon A Control Lens | Subjective Satisfaction | 74 units on a scale | Standard Deviation 19 |