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OpenTrials
Completed

NCT Number: NCT01244529

Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers

The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Farnham, Surrey, United Kingdom

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be at least 18 years of age and no more than 55 years of age.
  • Must sign written informed consent.
  • Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
  • Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
  • Must have visual acuity best correctable to 20/25+3 or better for each eye.
  • Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
  • The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.

Exclusion criteria

  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Any previous eye surgery involving the anterior segment.
  • Pre-existing ocular disease that would preclude contact lens fitting.
  • Abnormal lacrimal secretions.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrollment.
  • Participation in any concurrent clinical trial.
  • Subject's habitual contact lens type is toric or multifocal.
  • Require any concurrent ocular medication.

Treatment and study plan

galy A Plus

Device

galyfilcon A Plus, BC: 8.3 or 8.7

seno A

Device

senofilcon A, BC:8.4 or 8.8

galy A

Device

galyfilcon A , BC: 8.3 or 8.7

Primary outcomes

  1. Lens Centration Acceptance

    Time frame: after 15 minutes of contact lens wear

    Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.

  2. Primary Gaze Lens Movement

    Time frame: after 15 minutes of contact lens wear

    Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.

  3. Fit Acceptability

    Time frame: after 15 minutes of contact lens wear

    Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.

Secondary outcomes

  1. New Lens Power Fit Match to Control Lenses

    Time frame: after 15 minutes of contact lens wear

    The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 19, 2010
Registry last updated
Jun 19, 2018

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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