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The aim of the study is to investigate how Lid-Parallel Conjunctival Folds recovers or persists after the continued usage or discontinuation of contact lenses or refitting with low coefficient of friction lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spectacles Lens | Active Comparator | Participant will discontinue soft contact lens wear and wear spectacles only. Spectacle lens refers to the habitual prescription glasses that the participant arrives to the testing center with; they are NOT prescribed or given to the participant by the investigator as part of the study protocol. |
|
| Habitual Soft Contact Lens | Active Comparator | Participant will continue to wear their habitual soft contact lenses. Habitual lenses are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation. |
|
| Test Lens | Experimental | Participants will be dispensed senofilcon A or narafilcon A depending on their habitual modality (reusable or daily disposable) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectacle Lens | Device | Spectacle Lens Only |
| |
| Habitual Soft Contact Lens |
| Measure | Description | Time Frame |
|---|---|---|
| Lid-Parallel Conjunctival Folds (LIPCOF) | LIPCOF was assessed at baseline to 2-, 4-, 8- and 12- week Follow-up. Each subject eye was graded using a 4- point using the scale (Grade 0: No conjunctival folds, Grade 1: One permanent and clear parallel fold, Grade 2: Two permanent and clear parallel folds, (normally lower than 0.2mm) and Grade 3: More than two permanent and clear parallel folds, (normally higher than 0.2mm) at two 2 locations in the eye (Temporal and Nasal). The graded responses for each location (Temporal and Nasal) was average. The sum of the average LIPCOF grade for Temporal and Nasal was reported. (Score=average Nasal Grade + average Temporal Grade). | Baseline, 2-, 4-, 8- and 12-Week Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
Currently self reported pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear. This may include, but not be limited to, ocular/systemic pathology or allergy known to affect the conjunctiva, Sjogren's Syndrome, rheumatoid arthritis, diabetes, infections, hay-fever, or if they have had ocular surgery.
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
Any previous, or planned ocular or intra-ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection)on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other abnormality that may contraindicate contact lens wear.
Any ocular infection.
Monovision or multi-focal contact lens correction.
Participation in any contact lens or lens care product clinical trial within 90 days prior to study enrollment.
Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV,by self report).
Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician)
Contact lens wearing of OASYS or TruEye lenses
Contact lens wearing time less than 6h/day and/or 5 days/week
Extended wear of contact lenses.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weinheim | 69469 | Germany |
A total of 30 subjects were enrolled in this study. Of the enrolled subjects all 30 were dispensed study lenses and completed all study visits.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spectacles | Consists of subjects that were randomized to wear spectacles throughout the duration of the study. |
| FG001 | Habitual Soft Contact Lens | Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation. |
| FG002 | Senofilcon A or Narafilcon A | Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects that were randomized to a study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spectacles | Consists of subjects that were randomized to wear spectacles throughout the duration of the study. |
| BG001 | Habitual Soft Contact Lens | Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Lid-Parallel Conjunctival Folds (LIPCOF) | LIPCOF was assessed at baseline to 2-, 4-, 8- and 12- week Follow-up. Each subject eye was graded using a 4- point using the scale (Grade 0: No conjunctival folds, Grade 1: One permanent and clear parallel fold, Grade 2: Two permanent and clear parallel folds, (normally lower than 0.2mm) and Grade 3: More than two permanent and clear parallel folds, (normally higher than 0.2mm) at two 2 locations in the eye (Temporal and Nasal). The graded responses for each location (Temporal and Nasal) was average. The sum of the average LIPCOF grade for Temporal and Nasal was reported. (Score=average Nasal Grade + average Temporal Grade). | The analysis population consists of all subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | Score | Baseline, 2-, 4-, 8- and 12-Week Follow-up | observations | observations |
|
Throughout the duration of the study. Approximately 12- weeks per subject.
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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 | Spectacles | Consists of subjects that were randomized to wear spectacles throughout the duration of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, O.D., M.S.- Senior Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-3500 | 190 | BPALL@its.jnj.com |
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| Device |
subject's own contact lens |
|
| Test Lens | Device | senofilcon A or narafilcon A |
|
| BG002 | Senofilcon A or Narafilcon A | Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
| OG001 | Habitual Soft Contact Lens | Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation. |
| OG002 | Senofilcon A or Narafilcon A | Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable). |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Habitual Soft Contact Lens | Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation. | 0 | 10 | 0 | 10 |
| EG002 | Senofilcon A or Narafilcon A | Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable). | 0 | 10 | 0 | 10 |
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