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In-vivo Wettability Grading and Assessment Study (CIAN)

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ClinicalTrials.gov Identifier: NCT01010555
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : May 30, 2011
Last Update Posted : July 10, 2012
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.

Condition or disease Intervention/treatment Phase
Myopia Device: lotrafilcon B Device: balafilcon A Device: senofilcon A Device: enfilcon A Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: lotrafilcon B
Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
 Device: lotrafilcon B
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: Air Optix
Active Comparator: balafilcon A
Balafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
 Device: balafilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: PureVision
Active Comparator: senofilcon A
Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
 Device: senofilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: Acuvue OASYS
Active Comparator: enfilcon A
Enfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
 Device: enfilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: Avaira


Outcome Measures
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Primary Outcome Measures :
  1. On-eye Wettability [ Time Frame: 4 weeks of wear ]
    On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.


Eligibility Criteria
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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • is at least 17 years of age
  • has read and signed an information consent letter
  • is a current daily wear contact lens wearer
  • has acceptable fit with the study lenses
  • has had an ocular exam in the last two years
  • other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • has any ocular disease
  • has undergone corneal refractive surgery or is aphakic
  • has any systemic disease affecting ocular health
  • is pregnant or lactating
  • other protocol-defined exclusion criteria may apply
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010555


Locations
Canada, Ontario
Centre for Contact Lens Research: University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
CIBA VISION
University of Waterloo
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01010555     History of Changes
Other Study ID Numbers: P-368-C-104
First Posted: November 10, 2009    Key Record Dates
Results First Posted: May 30, 2011
Last Update Posted: July 10, 2012
Last Verified: January 2012