Presbyopia
Conditions
Brief summary
The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.
Interventions
DEVICEetafilcon A multifocal contact lens
low-add multifocal contact lens
DEVICEetafilcon A Contact Lens
standard sphere contact lens
Sponsors
Visioncare Research Ltd.
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 47 Years
Healthy volunteers
No
Inclusion criteria
* To have signed an informed consent form (documented by the investigator in the Case Report Form \[CRF\]). * Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed). * Between 35 and 47 years of age (inclusive). * Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes. * Refractive astigmatism of 0.75D or less in both eyes. * Visual symptoms associated with near vision * Be correctable to a visual acuity of 6/9 (20/30) or better in each eye. * Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: 1. No amblyopia. 2. No evidence of lid abnormality or infection. 3. No conjunctival abnormality or infection. 4. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities). 5. No other active ocular disease.
Exclusion criteria
* Monovision user or multifocal CL wearer. * Regular user of reading spectacles (i.e. daily usage). * Requires concurrent ocular medication. * Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear. * Corneal staining Grade 3 in more than two regions. * Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study. * Pre-existing ocular irritation that would preclude CL fitting. * Keratoconus or other corneal irregularity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire | week 4 | The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120. |
| Monocular Amplitude of Accommodation | week 4 | The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ | week 4 | Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly). |
| Subject Reported Lens Comfort Using CLUE Questionnaire | week 4 | Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range from 0 -120. |
| Comfortable Wearing Time | week 4 | Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable. |
| Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper | Baseline | Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects |
Countries
United States
Participant flow
Recruitment details
This was a four week, 49 subject, doubly-masked, daily wear, two-part crossover study. Recruited patients were emerging presbyopic (35-47 years) and soft CL wearing who were experiencing any near vision symptoms.
Pre-assignment details
A screening questionnaire (Near Vision Questionnaire, (NVQ)) was used to recruit subjects and to provide information about the wider population.
Participants by arm
| Arm | Count |
|---|---|
| Etafilcon A Multifocal/ Etafilcon A Sphere etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere). | 25 |
| Etafilcon A Sphere\ Etafilcon A Multifocal etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.
Repeat for the second lens (multifocal). | 24 |
| Total | 49 |
Baseline characteristics
| Characteristic | Etafilcon A Multifocal/ Etafilcon A Sphere | Etafilcon A Sphere\ Etafilcon A Multifocal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 24 Participants | 49 Participants |
| Age, Continuous | 42.3 years STANDARD_DEVIATION 3.4 | 42.3 years STANDARD_DEVIATION 3.4 | 42.3 years STANDARD_DEVIATION 3.4 |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Monocular Amplitude of Accommodation
The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.
Time frame: week 4
Population: Analysis was on those who were randomized to either treatment arm with intent to treat. One eye was chosen.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etafilcon A Multifocal | Monocular Amplitude of Accommodation | 0.00 diopters |
| Etafilcon A Sphere | Monocular Amplitude of Accommodation | 0.00 diopters |
Comparison: Ho: There is not a difference between the test lens and the control lens for amplitude of accommodation.~Ha: Monocular amplitude of accommodation of the test lens is significantly better than the control lens95% CI: [-0.09, 0.1]Mixed Models Analysis
Primary
Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.
Time frame: week 4
Population: Analysis was on those subjects enrolled, randomized into one of two randomized arms, and who completed the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etafilcon A Multifocal | Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire | 41.0 units on a scale |
| Etafilcon A Sphere | Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire | 39.0 units on a scale |
Comparison: Ho: There are not significant differences between the two lenses (etafilcon A multifocal (test) vs. etafilcon A sphere (control)for Vision quality.~Ha: The test lens is greater than or equal by 5 CLUE points than the control lense.95% CI: [-9.86, 1.59]Mixed Models Analysis
Secondary
Comfortable Wearing Time
Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable.
Time frame: week 4
Population: Analysis was on those subjects randomized to either arm with the intent to treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etafilcon A Multifocal | Comfortable Wearing Time | 14 hours |
| Etafilcon A Sphere | Comfortable Wearing Time | 14 hours |
Secondary
Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper
Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects
Time frame: Baseline
Population: Analysis was on those subjects who were randomized to either treatment arm with the intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etafilcon A Multifocal | Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper | 52 percentage of participants |
| Etafilcon A Sphere | Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper | 58 percentage of participants |
Secondary
Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ
Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly).
Time frame: week 4
Population: The NV Questionnaire was administered to those enrolled in the study and randomized to either treatment arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etafilcon A Multifocal | Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ | 53 percentage of participants |
| Etafilcon A Sphere | Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ | 43 percentage of participants |
Secondary
Subject Reported Lens Comfort Using CLUE Questionnaire
Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range from 0 -120.
Time frame: week 4
Population: Analysis was on those subjects enrolled and randomized to either one of the arms with intent to treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etafilcon A Multifocal | Subject Reported Lens Comfort Using CLUE Questionnaire | 59.0 units on a scale |
| Etafilcon A Sphere | Subject Reported Lens Comfort Using CLUE Questionnaire | 59.0 units on a scale |