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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014