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Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00583908
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : September 28, 2009
Last Update Posted : May 21, 2015
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE January 2, 2008
Results First Submitted Date  ICMJE August 18, 2009
Results First Posted Date  ICMJE September 28, 2009
Last Update Posted Date May 21, 2015
Study Start Date  ICMJE November 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 31, 2007)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2007)
Orientation at 8 different directions of gaze with head at the horizontal position. [ Time Frame: After each of the four lens insertions ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
Official Title  ICMJE Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3
Brief Summary 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.
Detailed Description Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, ~2 hour duration.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Astigmatism
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2008)
14
Original Estimated Enrollment  ICMJE
 (submitted: December 31, 2007)
17
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. be at least 18 and less than or equal to 50 years of age
  2. be able and willing to adhere to the instructions set forth in the protocol.
  3. have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
  4. Sign the STATEMENT OF INFORMED CONSENT.
  5. Have normal, healthy eyes

Exclusion Criteria:

  1. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
  2. Pre-existing ocular disease precluding contact lens fitting.
  3. Insufficient lacrimal secretions
  4. Aphakia, keratoconus or a highly irregular cornea
  5. Previous eye surgery involving the anterior segment
  6. Current pregnancy or lactation (to the best of the subject's knowledge).
  7. Use of concurrent ocular medication
  8. Active participation in another clinical study at any time during this study.-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00583908
Other Study ID Numbers  ICMJE CR-0710 pt 3
ETOR-507(under GNR-011)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Vision Care, Inc.
Study Sponsor  ICMJE Johnson & Johnson Vision Care, Inc.
Collaborators  ICMJE Visioncare Research Ltd.
Investigators  ICMJE
Principal Investigator: Graeme Young, BSc, MPhil Visioncare Research Ltd.
PRS Account Johnson & Johnson Vision Care, Inc.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP