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OpenTrials
Completed

NCT Number: NCT00708032

Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.

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Key information

Conditions

Refractive Error Eye Diseases Myopia Refractive Errors

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research, The University of Manchester

Manchester, Greater 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 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

Spectacles

Device

habitual spectacles

narafilcon A soft contact lenses

Device

narafilcon A daily disposable contact lenses

Primary outcomes

  1. Papillary Conjunctivitis

    Time frame: 12 months

    Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.

Secondary outcomes

  1. Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.

    Time frame: at 12 months

    Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.

  2. Visual Acuity After 12 Months of Wear

    Time frame: at 12 months

    Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.

  3. Subjective Overall Comfort After 12 Months of Daily Wear

    Time frame: at 12 months

    subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort

  4. Subjective Overall Vision After 12 Months of Daily Wear

    Time frame: at 12 months

    subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Collaborators

  • University of Manchester

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 2, 2008
Registry last updated
Dec 10, 2019

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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