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OpenTrials
Completed

NCT Number: NCT00584831

Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).

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Key information

Conditions

Astigmatism Behavior Eye Diseases Orientation, Spatial Refractive Errors Spatial Behavior

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience

Manchester, M60 1QD, United Kingdom

About this study

Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • They are aged between 18-39 years.
  • They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They can attain at least 6/9 in each eye with their spectacle refraction.
  • They have successfully worn contact lenses within six months of starting the study.
  • They can be fitted with toric soft contact lenses to match the available power range.

Exclusion criteria

  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  • They are pregnant or lactating.
  • They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  • They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Treatment and study plan

Senofilcon A

Device

toric contact lens

balafilcon A

Device

toric contact lens

omafilcon A

Device

toric contact lens

lotrafilcon B

Device

toric contact lens

Primary outcomes

  1. Visual Acuity After Infero-temporal Version Movement.

    Time frame: 10 minutes after insertion

    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.

  2. Visual Acuity After Infero-nasal Version Movement.

    Time frame: 10 minutes after lens insertion

    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.

  3. Visual Acuity After Superior-temporal Version Movement

    Time frame: 10 minutes after lens insertion

    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.

  4. Visual Acuity After Superior-nasal Version Movement.

    Time frame: 10 minutes after lens insertion

    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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Collaborators

  • University of Manchester

Registry information

Official study title

Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements

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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