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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myopia | Device: lotrafilcon B Device: balafilcon A Device: senofilcon A Device: enfilcon A | Not Applicable |
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 |
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.
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Device: lotrafilcon B
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: Air Optix
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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.
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Device: balafilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: PureVision
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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.
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Device: senofilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: Acuvue OASYS
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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.
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Device: enfilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
Other Name: Avaira
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- 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.

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

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
Canada, Ontario | |
Centre for Contact Lens Research: University of Waterloo | |
Waterloo, Ontario, Canada, N2L 3G1 |
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 |