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OpenTrials
Completed

NCT Number: NCT00912028

Clinical Performance Comparison of Several Different Contact Lenses

The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salvador, Estado de Bahia, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects must:

  • be existing soft contact lens wearers of the study control lenses
  • require a distance visual correction in both eyes
  • have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
  • have astigmatism less than or equal to 1.00D in both eyes
  • be able to wear lenses available for this study
  • be corrected to a visual acuity of 6/9 (20/30) or better in each eye
  • have normal eyes with no evidence of abnormality or disease

Exclusion criteria

Subject are excluded for the following reasons:

  • monovision corrected
  • worn lenses extended wear in the last 3 months.
  • require concurrent ocular medication
  • grade 3 or 4 abnormalities
  • grade 3 corneal staining in more than two regions
  • anterior ocular surgery
  • any other ocular surgery or injury within 8 weeks prior to study enrollment
  • abnormal lachrymal secretions
  • pre-existing ocular irritation that would preclude contact lens fitting
  • corneal irregularities
  • Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
  • any systemic illness which would preclude contact lens wear
  • diabetes
  • infectious or immunosuppressive disease
  • pregnancy or lactating, or planning pregnancy at time or enrollment
  • participating in a concurrent clinical study or within last 60 days
  • allergy to the standardized study care solution

Treatment and study plan

Senofilcon A

Device

contact lens

lotrafilcon B

Device

contact lens

balafilcon A

Device

contact lens

methafilcon A

Device

contact lens

vifilcon A

Device

contact lens

Primary outcomes

  1. Limbal Hyperemia (Redness)

    Time frame: 2 weeks

    Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

  2. Limbal Hyperemia (Redness)

    Time frame: 4 weeks

    Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

  3. Bulbar Hyperemia (Redness)

    Time frame: 2 weeks

    Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

  4. Bulbar Hyperemia (Redness)

    Time frame: 4 weeks

    Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

  5. Corneal Staining

    Time frame: 2 weeks

    Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

  6. Corneal Staining

    Time frame: 4 weeks

    Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Official study title

Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2009
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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