December 21, 2007
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January 2, 2008
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August 18, 2009
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September 28, 2009
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May 21, 2015
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November 2007
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January 2008 (Final data collection date for primary outcome measure)
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- Lens Orientation During Head Tilt. [ Time Frame: after fit of each of the four lens insertions ]
Degree of lens rotation on the eye with the head tilted.
- Visual Acuity During Head Tilt [ Time Frame: after each of the four lens insertions ]
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity.
logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
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- Lens Orientation During Head Tilt. [ Time Frame: after fit of each of the four lens insertions ]
- Visual Acuity During Head Tilt [ Time Frame: after each of the four lens insertions ]
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- Degree of Lens Rotation in Superior Gaze. [ Time Frame: After each of the four lens insertions ]
Degree of lens rotation while participant is gazing up.
- Degree of Lens Rotation in Superior-temporal Gaze. [ Time Frame: After each of 4 lens insertions., ]
Degree of lens rotation while participant is gazing up and out(towards the temple).
- Degree of Lens Rotation in Superior-nasal Gaze. [ Time Frame: After each of the four lens insertions ]
Degree of lens rotation while participant is gazing up and in(towards the nose).
- Degree of Lens Rotation in Temporal Gaze. [ Time Frame: After each of the four lens insertions ]
Degree of lens rotation while participant is gazing out(towards the temple).
- Degree of Lens Rotation in Nasal Gaze. [ Time Frame: After each of the four lens insertions ]
Degree of lens rotation while participant is gazing in(towards the nose).
- Degree of Lens Rotation Inferior-temporal Gaze. [ Time Frame: After each of the four lens insertions ]
Degree of lens rotation while participant is gazing down and out.
- Degree of Lens Rotation in Inferior-nasal Gaze. [ Time Frame: After each of the four lens insertions ]
Degree of lens rotation while participant is gazing down and in.
- Degree of Lens Rotation in Inferior Gaze. [ Time Frame: After each of the four lens insertions ]
Degree of lens rotation while participant is gazing down.
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Orientation at 8 different directions of gaze with head at the horizontal position. [ Time Frame: After each of the four lens insertions ]
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Not Provided
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Not Provided
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Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
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Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3
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The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.
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Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, ~2 hour duration.
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Interventional
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Not Applicable
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Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Treatment
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Astigmatism
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- Device: senofilcon A
toric contact lens
- Device: balafilcon A toric
toric contact lens
- Device: lotrafilcon B toric
toric contact lens
- Device: omafilcon A
toric contact lens
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- Active Comparator: Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
- Active Comparator: Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A
One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A
Interventions:
- Device: senofilcon A
- Device: balafilcon A toric
- Device: lotrafilcon B toric
- Device: omafilcon A
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Not Provided
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Completed
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14
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17
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January 2008
|
January 2008 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- be at least 18 and less than or equal to 50 years of age
- be able and willing to adhere to the instructions set forth in the protocol.
- have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
- Sign the STATEMENT OF INFORMED CONSENT.
- Have normal, healthy eyes
Exclusion Criteria:
- The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
- Pre-existing ocular disease precluding contact lens fitting.
- Insufficient lacrimal secretions
- Aphakia, keratoconus or a highly irregular cornea
- Previous eye surgery involving the anterior segment
- Current pregnancy or lactation (to the best of the subject's knowledge).
- Use of concurrent ocular medication
- Active participation in another clinical study at any time during this study.-
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Sexes Eligible for Study: |
All |
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18 Years to 50 Years (Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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United Kingdom
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NCT00583908
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CR-0710 pt 3 ETOR-507(under GNR-011)
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No
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Not Provided
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Not Provided
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Johnson & Johnson Vision Care, Inc.
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Johnson & Johnson Vision Care, Inc.
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Visioncare Research Ltd.
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Principal Investigator: |
Graeme Young, BSc, MPhil |
Visioncare Research Ltd. |
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Johnson & Johnson Vision Care, Inc.
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May 2015
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