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OpenTrials
Completed

NCT Number: NCT01007812

Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a current spectacle prescription, preferably within 6-9 months.
  • Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
  • Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
  • Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

  • Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
  • Currently enrolled in any Clinical Trial.
  • Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • Currently wearing soft toric contact lenses as extended wear.
  • Currently wearing either of the products to be worn in the study.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Lotrafilcon B contact lens

Device

Silicone hydrogel, toric, soft contact lens

Comfilcon A contact lens

Device

Silicone hydrogel, toric, soft contact lens

Primary outcomes

  1. Overall Vision

    Time frame: After 1 week of wear

    Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 4, 2009
Registry last updated
Jun 29, 2012

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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