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

• 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: Johnson & Johnson Vision Care, Inc.
• Collaborator: Visioncare Research Ltd.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Tracking Information

• First Submitted Date: December 21, 2007
• First Posted Date: January 2, 2008
• Results First Submitted Date: August 18, 2009
• Results First Posted Date: September 28, 2009
• Last Update Posted Date: May 21, 2015
• Study Start Date: November 2007
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 10, 2011)

• 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 (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 ]

Current Secondary Outcome Measures (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 (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: Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Astigmatism

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 19, 2008): 14
• Original Estimated Enrollment (submitted: December 31, 2007): 17
• Actual Study Completion Date: January 2008
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00583908
• Other Study ID Numbers: CR-0710 pt 3; ETOR-507(under GNR-011)
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Johnson & Johnson Vision Care, Inc.
• Study Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.

Investigators

• Principal Investigator: Graeme Young, BSc, MPhil; Visioncare Research Ltd.

• PRS Account: Johnson & Johnson Vision Care, Inc.
• Verification Date: May 2015