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In-vivo Wettability Grading and Assessment Study (CIAN)

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
lotrafilcon B
balafilcon A
senofilcon A
enfilcon A
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Contact Lens Research: University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

lotrafilcon B

balafilcon A

senofilcon A

enfilcon A

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

On-eye Wettability
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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2009
Last Updated
June 26, 2012
Sponsor
CIBA VISION
Collaborators
University of Waterloo
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1. Study Identification

Unique Protocol Identification Number
NCT01010555
Brief Title
In-vivo Wettability Grading and Assessment Study
Acronym
CIAN
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
Collaborators
University of Waterloo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lotrafilcon B
Arm Type
Active Comparator
Arm Description
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.
Arm Title
balafilcon A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
senofilcon A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
enfilcon A
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
lotrafilcon B
Other Intervention Name(s)
Air Optix
Intervention Description
Commercially marketed, silicone hydrogel, spherical contact lens
Intervention Type
Device
Intervention Name(s)
balafilcon A
Other Intervention Name(s)
PureVision
Intervention Description
Commercially marketed, silicone hydrogel, spherical contact lens
Intervention Type
Device
Intervention Name(s)
senofilcon A
Other Intervention Name(s)
Acuvue OASYS
Intervention Description
Commercially marketed, silicone hydrogel, spherical contact lens
Intervention Type
Device
Intervention Name(s)
enfilcon A
Other Intervention Name(s)
Avaira
Intervention Description
Commercially marketed, silicone hydrogel, spherical contact lens
Primary Outcome Measure Information:
Title
On-eye Wettability
Description
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.
Time Frame
4 weeks of wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre for Contact Lens Research: University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

In-vivo Wettability Grading and Assessment Study

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