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

This study has been completed.
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00583908
First received: December 21, 2007
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Astigmatism
Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Lens Orientation During Head Tilt. [ Time Frame: after fit of each of the four lens insertions ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Degree of Lens Rotation in Superior Gaze. [ Time Frame: After each of the four lens insertions ] [ Designated as safety issue: No ]
    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., ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Degree of lens rotation while participant is gazing down.


Enrollment: 14
Study Start Date: November 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Detailed Description:

Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, ~2 hour duration.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.-
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583908

Locations
United Kingdom
Visioncare Research Ltd.
Farnham, United Kingdom, GU9 7EN
Sponsors and Collaborators
Vistakon
Visioncare Research Ltd.
Investigators
Principal Investigator: Graeme Young, BSc, MPhil Visioncare Research Ltd.
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00583908     History of Changes
Other Study ID Numbers: CR-0710 pt 3, ETOR-507(under GNR-011)
Study First Received: December 21, 2007
Results First Received: August 18, 2009
Last Updated: May 27, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Vistakon:
astigmatism
orientation
visual acuity
contact lenses

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 21, 2014