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Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
This study has been completed.
Sponsors and Collaborators: Vistakon
University of Manchester
Information provided by: Vistakon
ClinicalTrials.gov Identifier: NCT00708643
  Purpose

This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.


Condition Intervention
Refractive Error
Myopia
Device: Habitual Contact Lens
Device: narafilcon A

MedlinePlus related topics: Eye Wear Refractive Errors
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Clinical biomicroscopic findings [ Time Frame: Baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
  • Comfort [ Time Frame: Baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical biomicroscopic findings [ Time Frame: Baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Habitual lens wear.
Device: Habitual Contact Lens
contact lens
2: Experimental
Daily Disposable Contact Lens
Device: narafilcon A
contact lens

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. They are of legal age (17 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708643

Locations
Canada, Ontario
Centre for Contact Lens Research
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Vistakon
University of Manchester
  More Information

Responsible Party: Vistakon ( Kurt Moody, O.D., FAOO / Associate Director, Clinical Research )
Study ID Numbers: CR-0803
Study First Received: June 27, 2008
Last Updated: September 8, 2008
ClinicalTrials.gov Identifier: NCT00708643  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Eye Diseases
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on January 14, 2009