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OpenTrials
Completed

NCT Number: NCT01097863

Clinical Validation of the New Print on Focus DAILIES Toric

The purpose of this study is to validate the improvements to the inversion indicator.

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
  • Willing and able to wear study lenses in both eyes in the available parameters.
  • Light-eyed subjects.
  • Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
  • Optimal or acceptable fit in each eye at time of dispensing.
  • Willing to wear the study lenses at least 8 hours a day, 5 days a week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Eye injury or surgery within twelve weeks prior to enrollment for this trial.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in an ophthalmic 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.
  • RGP contact lens wearer.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

nelfilcon A contact lens, modified inversion indicator

Device

Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator

nelfilcon A contact lens, no inversion indicator

Device

Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator

nelfilcon A contact lens, inversion indicator

Device

Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator

Other names: Focus DAILIES Toric

Primary outcomes

  1. Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.

    Time frame: 1 week

    As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 2, 2010
Registry last updated
Jul 10, 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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