In-vivo Wettability Grading and Assessment Study (CIAN)

June 26, 2012 updated by: CIBA VISION
The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.
Device: lotrafilcon B
Commercially marketed, silicone hydrogel, spherical contact lens
Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Avaira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks of wear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CIBA VISION

Collaborators

University of Waterloo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (ESTIMATE)

November 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-368-C-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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