Skip to main content
OpenTrials
Completed

NCT Number: NCT00708643

Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population

This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Refractive Error Eye Diseases Myopia Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

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 (17 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 with 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 successfully worn 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 oedema, corneal vascularisation, 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 have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Treatment and study plan

Habitual Silicone Hydrogel Contact Lens

Device

contact lens

narafilcon A

Device

contact lens

Primary outcomes

  1. Limbal Hyperemia

    Time frame: At 2 weeks and 4 weeks

    Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.

  2. Lens Comfort

    Time frame: At 3,7,10,13,17,21,24, and 27 days

    Rating of lens comfort by rating agreement to the following statement:

    "The lenses I am wearing are comfortable."

    Rating using the following scale:

    1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.

  3. Upper Lid Margin Staining

    Time frame: At 2 weeks and 4 weeks.

    Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.

Secondary outcomes

  1. Tarsal Roughness

    Time frame: At 2 weeks and 4 weeks

    Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.

  2. Tarsal Hyperemia

    Time frame: At 2 weeks and 4 weeks.

    Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.

  3. Corneal Staining

    Time frame: At 2 weeks and 4 weeks.

    A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Collaborators

  • University of Manchester

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 2, 2008
Registry last updated
May 21, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.