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Completed

NCT Number: NCT00583908

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

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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Key information

Conditions

Astigmatism Behavior Eye Diseases Orientation, Spatial Refractive Errors Spatial Behavior

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Visioncare Research Ltd.

Farnham, GU9 7EN, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.-

Treatment and study plan

Senofilcon A

Device

toric contact lens

balafilcon A toric

Device

toric contact lens

lotrafilcon B toric

Device

toric contact lens

omafilcon A

Device

toric contact lens

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Collaborators

  • Visioncare Research Ltd.

Registry information

Official study title

Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 2, 2008
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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