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A Comparison of Two Daily Disposable Contact Lenses.

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ClinicalTrials.gov Identifier: NCT00721500
Recruitment Status : Completed
First Posted : July 24, 2008
Results First Posted : March 2, 2011
Last Update Posted : May 21, 2015
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Description
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Brief Summary:
This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.

Condition or disease Intervention/treatment Phase
Refractive Error Myopia Device: etafilcon A Device: narafilcon A Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of the Lens Fit of Narafilcon A Soft Contact Lenses
Study Start Date : June 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: narafilcon A / etafilcon A - etafilcon A - narafilcon A
First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
 Device: etafilcon A
contact lens
Other Name: 1-Day Acuvue Moist

Device: narafilcon A
contact lens
Other Name: TruEye
Experimental: narafilcon A / etafilcon A - narafilcon A - etafilcon A
First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
 Device: etafilcon A
contact lens
Other Name: 1-Day Acuvue Moist

Device: narafilcon A
contact lens
Other Name: TruEye
Experimental: narafilcon A - etafilcon A - narafilcon A / etafilcon A
First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
 Device: etafilcon A
contact lens
Other Name: 1-Day Acuvue Moist

Device: narafilcon A
contact lens
Other Name: TruEye
Experimental: etafilcon A - narafilcon A - narafilcon A / etafilcon A
First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
 Device: etafilcon A
contact lens
Other Name: 1-Day Acuvue Moist

Device: narafilcon A
contact lens
Other Name: TruEye


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Eyes Successfully Fit [ Time Frame: Within 20 minutes of lens insertion ]
    Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.

  2. Lens Fit Decentration [ Time Frame: Within 20 minutes of lens insertion ]
    Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.

  3. Lens Tightness on Cornea With Manual Digit Push Up [ Time Frame: Within 20 minutes of lens insertion ]
    Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT00721500


Locations
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United Kingdom
Visioncare Research Ltd
Farnham, Surrey, United Kingdom, GU9 7EN
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Visioncare Research Ltd.
More Information
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00721500    
Other Study ID Numbers: CR-0812
PROD-502
First Posted: July 24, 2008    Key Record Dates
Results First Posted: March 2, 2011
Last Update Posted: May 21, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases