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| ID | Type | Description | Link |
|---|---|---|---|
| VMFL-511 | Other Identifier | Visioncare Research, Ltd. |
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| Name | Class |
|---|---|
| Visioncare Research Ltd. | OTHER |
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The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A multifocal / etafilcon A sphere | Other | period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn. |
|
| etafilcon A sphere / etafilcon A multifocal | Other | period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A multifocal contact lens | Device | low-add multifocal contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 4 |
| 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. | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | week 4 |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Little Rock | Arkansas | United States | ||||
A screening questionnaire (Near Vision Questionnaire, (NVQ)) was used to recruit subjects and to provide information about the wider population.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was on those subjects enrolled, randomized into one of two randomized arms, and who completed the study. | Posted | Median | Inter-Quartile Range | units on a scale | week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etafilcon A Multifocal | etafilcon A multifocal worn |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen OD, MS, FAAO Senior Principal Research Optometrist | Johnson & Johnson Vision Care | (904)443-3402 | TKarkkai@its.jnj.com |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| etafilcon A Contact Lens | Device | standard sphere contact lens |
|
| 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. | week 4 |
| 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. | week 4 |
| 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 | Baseline |
| Blue Springs |
| Missouri |
| United States |
| Lake Ozark | Missouri | United States |
| Warren | Ohio | United States |
| Kittanning | Pennsylvania | United States |
| Warwick | Rhode Island | United States |
| Chamberlain | South Dakota | United States |
| Burlington | Vermont | United States |
| NOT COMPLETED |
|
| 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean age was the same for both groups. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
etafilcon A sphere worn |
|
|
|
| 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. | Analysis was on those who were randomized to either treatment arm with intent to treat. One eye was chosen. | Posted | Median | Inter-Quartile Range | diopters | week 4 |
|
|
|
|
| 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). | The NV Questionnaire was administered to those enrolled in the study and randomized to either treatment arm. | Posted | Number | percentage of participants | week 4 |
|
|
|
| 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. | Analysis was on those subjects enrolled and randomized to either one of the arms with intent to treat. | Posted | Median | Inter-Quartile Range | units on a scale | week 4 |
|
|
|
| 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. | Analysis was on those subjects randomized to either arm with the intent to treat. | Posted | Median | Inter-Quartile Range | hours | week 4 |
|
|
|
| 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 | Analysis was on those subjects who were randomized to either treatment arm with the intent to treat. | Posted | Number | percentage of participants | Baseline |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Etafilcon A Sphere | etafilcon A sphere worn | 0 | 49 | 0 | 49 |
Written authorization by the Sponsor is required for publication.