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Primary Hypotheses:
Senofilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 monthly .
Etafilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 1 1 day .
Etafilcon A will provide rotation with subjects a recumbent position non-inferior to nelfilcon A. A margin of 5 degrees will be used.
Secondary Hypotheses:
Senofilcon A will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 monthly.
Etafilcon A for astigmatism will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 1 day.
Etafilcon A will have monocular visual performance with subjects in a recumbent position non-inferior nelfilcon A. A margin of 0.05 LogMAR will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, nelfilcon A, etafilcon A, senofilcon A, Filcon II 3 |
|
| Sequence 2 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, nelfilcon A, etafilcon A, Filcon II 3, senofilcon A |
|
| Sequence 3 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, etafilcon A, nelfilcon A, senofilcon A, Filcon II 3 |
|
| Sequence 4 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: Filcon II 3, etafilcon A, nelfilcon A, Filcon II 3, senofilcon A |
|
| Sequence 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | bilateral daily use soft contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Orientation in Recumbent Position | rotation from zero position also described as absolute value of the rotation. | up to 60 minutes in recumbent position |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Visual Acuity in Recumbent Position | Visual Acuity measured in LogMAR units. High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted). | up to 60 minutes in recumbent position |
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Inclusion Criteria:
Age range 18-60 years.
Read, understand, and sign written Statement of Informed Consent.
Appear able and willing to adhere to the instructions set forth in the clinical protocol.
Be existing soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
Require a visual correction in both eyes (monovision allowed but no monofit).
Have a spherical contact lens requirement in the range -1.00 to -6.00D.
Have astigmatism of between -0.75 and -2.00DC in both eyes.
Have axes of astigmatism within +/-10° of the following available lens axes: 70°, 90°, 110°, 20°, 180° & 160°, i.e. 60-120, 10-30 and 150-180.
Monocular distance visual acuity correctable to 6/9 or better in each eye with best sphero-cylindrical refraction.
Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having:
i) Clear cornea ii) No anterior segment disorder iii) No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities) iv) No other active ocular disease or recent surgery
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Farnham | Surrey | GU97EN | United Kingdom |
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Subjects were recruited and screened based on the inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | All subjects who were enrolled. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Twenty-four subjects were screened, enrolled and completed each of the two arms of the study. No subjects were deemed ineligible on screening.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Subjects | All subjects who were enrolled, and completed the study. |
| 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 | Lens Orientation in Recumbent Position | rotation from zero position also described as absolute value of the rotation. | Subjects analyzed were those enrolled, randomized, and whom completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | degrees | up to 60 minutes in recumbent position |
|
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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 | Senofilcon A (AOfA) | As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Osborn Lorenz, OD MS | Vistakon/Johnson & Johnson Vision Care | 904-443-3123 | kosborn@its.jnj.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Experimental |
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, Filcon II 3, etafilcon A, senofilcon A, Filcon II 3 |
|
| Sequence 6 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, Filcon II 3, etafilcon A, Filcon II 3, senofilcon A |
|
| Sequence 7 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, etafilcon A, Filcon II 3, senofilcon A, Filcon II 3 |
|
| Sequence 8 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: nelfilcon A, etafilcon A, Filcon II 3, Filcon II 3, senofilcon A |
|
| Sequence 9 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, Filcon II 3, nelfilcon A, senofilcon A, Filcon II 3 |
|
| Sequence 10 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, Filcon II 3, nelfilcon A, Filcon II 3, senofilcon A |
|
| Sequence 11 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, nelfilcon A, Filcon II 3, senofilcon A, Filcon II 3 |
|
| Sequence 12 | Experimental | Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows: etafilcon A, nelfilcon A, Filcon II 3, Filcon II 3, senofilcon A |
|
| etafilcon A | Device | bilateral daily use soft contact lens |
|
| nelfilcon A | Device | bilateral daily use soft contact lens |
|
| Filcon II 3 | Device | bilateral daily use soft contact lens |
|
| Filcon II 3 | Device | bilateral daily use soft contact lenses |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits. |
| OG002 | Etafilcon A (1DAMfA) | As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits. |
| OG003 | Filcon II 3 (C1DT) | As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits. |
| OG004 | Nelfilcon A (FDT) | As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits. |
|
|
| Secondary | Monocular Visual Acuity in Recumbent Position | Visual Acuity measured in LogMAR units. High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted). | Analysis is on those who were enrolled, randomized, and whom completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale (LogMAR) | up to 60 minutes in recumbent position |
|
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|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Filcon II 3 (Sauflon) | As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits. | 0 | 24 | 0 | 24 |
| EG002 | Etafilcon A (1DAMfA) | As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits. | 0 | 24 | 0 | 24 |
| EG003 | Filcon II 3 (C1DT) | As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits. | 0 | 24 | 0 | 24 |
| EG004 | Nelfilcon A (FDT) | As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits. | 0 | 24 | 0 | 24 |
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