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A Comparison of Two Contact Lenses

This study has been completed.

Sponsored by: Vistakon
Information provided by: Vistakon
ClinicalTrials.gov Identifier: NCT00700752
  Purpose

This study seeks to evaluate the clinical and subjective performance of two established soft contact lenses.


Condition Intervention
Refractive Error
Myopia
Device: senofilcon A
Device: balafilcon A

MedlinePlus related topics:   Eye Wear    Refractive Errors   

Drug Information available for:   Balafilcon A    Senofilcon A   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Patient-reported comfort [ Time Frame: after 1 and 2 week of wear ] [ Designated as safety issue: No ]

Enrollment:   40
Study Start Date:   May 2008
Study Completion Date:   July 2008
Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
2: Active Comparator
contact lens
Device: balafilcon A
contact lens
1: Active Comparator
contact lens
Device: senofilcon A
contact lens

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700752

Locations
United States, Indiana
Indiana University    
      Bloomington, Indiana, United States, 47405

Sponsors and Collaborators
Vistakon
  More Information


Responsible Party:   Vistakon ( Kurt Moody, OD, FAOO / Associate Director, Clinical Research )
Study ID Numbers:   CR-0728
First Received:   June 17, 2008
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00700752
Health Authority:   United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 24, 2008




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