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OpenTrials
Completed

NCT Number: NCT01444287

Daytime Corneal Swelling During Wear of Narafilcon B Lenses

The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coles-Brennan Pty Ltd

Hawthorn, Victoria, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be of legal age (i.e. ≥ 18 years).
  • Be mentally competent, willing and able to sign a written informed consent form.
  • Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
  • Have spectacle astigmatism <1.25D in each eye.
  • Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
  • Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.

Exclusion criteria

  • Required concurrent ocular medication.
  • Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
  • Abnormal lacrimal secretions.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrollment.
  • Participation in any concurrent clinical trial.

Treatment and study plan

narafilcon B

Device

test product

polymacon

Device

marketed product

lotrafilcon A

Device

marketed product

spectacles

Other

None - subject used own spectacles

Primary outcomes

  1. Corneal Thickness

    Time frame: After 8 hours of contact lens wear

    Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.

  2. Endothelial Blebs

    Time frame: baseline, after 20 minutes of treatment conditions

    Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).

  3. Limbal Redness

    Time frame: Baseline, After 8 hours of treatment conditions

    Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.

Secondary outcomes

  1. Overall Comfort

    Time frame: after 8 hours

    Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).

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
Sep 30, 2011
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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