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A Comparison of Two Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00700752
First received: June 17, 2008
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A). [ Time Frame: after 4 weeks of lens wear ] [ Designated as safety issue: No ]
    Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.


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
Active Comparator: senofilcon A/balafilcon A
senofilcon A silicone hydrogel contact lens worn during first 4-week period, balafilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.
 Device: senofilcon A
silicone hydrogel contact lens
Device: balafilcon A
silicone hydrogel contact lens
Active Comparator: balafilcon A/senofilcon A
balafilcon A silicone hydrogel contact lens worn worn during first 4-week period, senofilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.
 Device: senofilcon A
silicone hydrogel contact lens
Device: balafilcon A
silicone hydrogel 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

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00700752     History of Changes
Other Study ID Numbers: CR-0728
Study First Received: June 17, 2008
Results First Received: August 25, 2010
Last Updated: November 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013