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In-vivo Wettability Grading and Assessment Study (CIAN)

This study has been completed.
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01010555
First received: November 9, 2009
Last updated: June 26, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.


Condition Intervention
Myopia
 Device: lotrafilcon B
Device: balafilcon A
Device: senofilcon A
Device: enfilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • On-eye Wettability [ Time Frame: 4 weeks of wear ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01010555     History of Changes
Other Study ID Numbers: P-368-C-104
Study First Received: November 9, 2009
Results First Received: May 3, 2011
Last Updated: June 26, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013