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 (Participant, Outcomes Assessor) Primary Purpose: Treatment

Further study details as provided by Alcon Research ( CIBA VISION ):

Primary Outcome Measures:

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.


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 (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

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


Responsible Party:	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

ClinicalTrials.gov processed this record on July 19, 2017

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