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OpenTrials
Completed

NCT Number: NCT00762996

The Clinical Evaluation of Two Daily Disposable Contact Lenses

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research

Manchester, M60 1QD, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • They are of legal age (18 years) and capacity to volunteer.
  • They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.
  • They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.
  • They have a maximum of 1.00D of refractive astigmatism (i.e. < 1.00 DC).
  • They have worn soft contact lenses within six months of starting the study.

Exclusion criteria

  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
  • They are pregnant or lactating.
  • They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  • They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).
  • They have diabetes.
  • They are currently taking part in any other clinical study or research.

Treatment and study plan

etafilcon A

Device

contact lens

omafilcon A

Device

contact lens

Primary outcomes

  1. Distance Visual Acuity

    Time frame: 1 week

    logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

Secondary outcomes

  1. Lens Comfort

    Time frame: 1 week

    A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Collaborators

  • Eurolens Research

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 30, 2008
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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