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OpenTrials
Completed

NCT Number: NCT01163760

Clinical Evaluation of Two Daily Disposable Contact Lenses

This study seeks to evaluate the clinical performance of two daily disposable contact lenses.

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Key information

Age range

21 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be between 21 and 39 years of age.
  • Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
  • Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
  • Require a visual correction in both eyes (monovision allowed but no monofit).
  • Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
  • Astigmatism of 1.00D or less in both eyes.
  • Be able to wear the lens powers available for this study.
  • Be correctable to a visual acuity of 20/30 or better in each eye.
  • 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 amblyopia.
  • No evidence of lid abnormality or infection.
  • No conjunctival abnormality or infection.
  • No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
  • No other active ocular disease.

Exclusion criteria

  • Requires concurrent ocular medication.
  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Diabetic.
  • Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • Extended lens wear in last 3 months.
  • PMMA or RGP lens wear in the previous 8 weeks.
  • Has had refractive surgery. Has had eye injury/surgery within 8 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 or in last 60 days."

Treatment and study plan

etafilcon A

Device

daily disposable contact lens

ocufilcon D

Device

daily disposable contact lens

Primary outcomes

  1. Lens Comfort

    Time frame: 1-week follow-up

    Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)

Secondary outcomes

  1. Comfort Throughout the Whole Day

    Time frame: 1-week follow-up

    Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".

Other outcomes

  1. Comfort While Working on Computer

    Time frame: 1-week-follow-up

    Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Collaborators

  • Singapore Polytechnic University
  • Visioncare Research Ltd.

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 16, 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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