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

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ClinicalTrials.gov Identifier: NCT00708032
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : December 8, 2011
Last Update Posted : May 21, 2015
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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

Condition or disease Intervention/treatment Phase
Refractive Error Myopia Device: spectacles Device: narafilcon A soft contact lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
Study Start Date : June 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
spectacles
habitual spectacles worn daily for 12 months
Device: spectacles
habitual spectacles

Experimental: narafilcon A soft contact lenses
narafilcon A soft contact lenses worn as daily disposable for 12 months
Device: narafilcon A soft contact lenses
narafilcon A daily disposable contact lenses




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. They are of legal age (18 years) and capacity to volunteer.
  2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
  5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
  6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
  7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They are aphakic.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
  7. They are pregnant or lactating.
  8. 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.
  9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
  10. They have diabetes.
  11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708032


Locations
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United Kingdom
Eurolens Research, The University of Manchester
Manchester, Greater Manchester, United Kingdom, M60 1QD
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
University of Manchester

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00708032     History of Changes
Other Study ID Numbers: CR-0806
First Posted: July 2, 2008    Key Record Dates
Results First Posted: December 8, 2011
Last Update Posted: May 21, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases