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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 28, 2014
Last verified: October 2014
  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
Official Title: An Evaluation of the Lens Fit of Narafilcon A Soft Contact Lenses

Resource links provided by NLM:


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 ]
    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'.

  • Lens Fit Decentration [ Time Frame: Within 20 minutes of lens insertion ] [ Designated as safety issue: No ]
    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.

  • Lens Tightness on Cornea With Manual Digit Push Up [ Time Frame: Within 20 minutes of lens insertion ] [ Designated as safety issue: No ]
    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.


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 28, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on November 25, 2014