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A Comparison of Two Daily Disposable Contact Lenses.

This study has been completed.
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00721500
First received: July 22, 2008
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  Purpose

This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.


Condition Intervention
Refractive Error
Myopia
 Device: etafilcon A
Device: narafilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Proportion of Eyes Successfully Fit [ Time Frame: within 20 minutes of lens insertion ] [ Designated as safety issue: No ]
    Fitting success based on lens fit as assessed by investigator observation using the following: 1 = successful, 0 = unsuccessful.

  • Lens Fit Decentration [ Time Frame: within 20 minutes of lens insertion ] [ Designated as safety issue: No ]
    Amount of lens decentration measured in mm. A lower value is best.

  • Lens Tightness on Cornea With Manual Digit Push Up [ Time Frame: within 20 minutes of lens insertion ] [ Designated as safety issue: No ]
    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% scale where, 50% is regarded as being optimum while lower than this is tending towards looseness and greater is tending towards tightness.


Enrollment: 25
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: narafilcon A - etafilcon A/etafilcon A/narafilcon A
First intervention is narafilcon A contact lens in the right eye and etafilcon A contact lens in the left eye. Second intervention is etafilcon A contact lenses worn in both eyes. Third intervention is narafilcon A contact lenses worn in both eyes.
 Device: etafilcon A
contact lens
Device: narafilcon A
contact lens
Active Comparator: etafilcon A - narafilcon A/narafilcon A/etafilcon A
First intervention is etafilcon A contact lens in the right eye and narafilcon A contact lens in the left eye. Second intervention is narafilcon A contact lenses worn in both eyes. Third intervention is etafilcon A contact lenses worn in both eyes.
 Device: etafilcon A
contact lens
Device: narafilcon A
contact lens
Active Comparator: narafilcon A/etafilcon A/narafilcon A - etafilcon A
First intervention is narafilcon A contact lenses worn in both eyes. Second intervention is etafilcon A contact lenses worn in both eyes. Third intervention is narafilcon A contact lens in the right eye and etafilcon A contact lens in the left eye.
 Device: etafilcon A
contact lens
Device: narafilcon A
contact lens
Active Comparator: narafilcon A/etafilcon A/etafilcon A - narafilcon A
First intervention is narafilcon A contact lenses worn in both eyes. Second intervention is etafilcon A contact lenses worn in both eyes. Third intervention is etafilcon A contact lens in the right eye and narafilcon A contact lens in the left eye.
 Device: etafilcon A
contact lens
Device: narafilcon A
contact lens
Active Comparator: etafilcon A/narafilcon A/narafilcon A - etafilcon A
First intervention is etafilcon A contact lenses worn in both eyes. Second intervention is narafilcon A contact lenses worn in both eyes. Third intervention is narafilcon A contact lens in the right eye and etafilcon A contact lens in the left eye.
 Device: etafilcon A
contact lens
Device: narafilcon A
contact lens
Active Comparator: etafilcon A/narafilcon A/etafilcon A - narafilcon A
First intervention is etafilcon A contact lenses worn in both eyes. Second intervention is narafilcon A contact lenses worn in both eyes. Third intervention is etafilcon A contact lens in the right eye and narafilcon A contact lens in the left eye.
 Device: etafilcon A
contact lens
Device: narafilcon A
contact lens

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721500

Locations
United Kingdom
Visioncare Research Ltd
Farnham, Surrey, United Kingdom, GU9 7EN
Sponsors and Collaborators
Vistakon
Visioncare Research Ltd.
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00721500     History of Changes
Other Study ID Numbers: CR-0812, PROD-502
Study First Received: July 22, 2008
Results First Received: May 7, 2010
Last Updated: October 10, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013