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Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (QUINCE)

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Narafilcon A contact lens

Lotrafilcon A contact lens

Galyfilcon A contact lens

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 and has full legal capacity to volunteer
Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
Has had an ocular examination in the last two years
Is a current soft (hydrogel or silicone hydrogel) contact lens wearer
Has clear corneas and no active ocular disease
Can be successfully fit with the lenses to be used in the study
Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

Is pregnant or lactating
Has undergone corneal refractive surgery
Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study
Other protocol-defined inclusion/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 Type

Active Comparator

Arm Label

Lotrafilcon A

Narafilcon A

Galyfilcon A

Arm Description

Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Outcomes

Primary Outcome Measures

Front Surface Lens Deposits

Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.

Secondary Outcome Measures

Full Information

NCT ID

NCT00934102

First Posted

July 6, 2009

Last Updated

June 26, 2012

Sponsor

CIBA VISION

Collaborators

University of Waterloo

1. Study Identification

Unique Protocol Identification Number

NCT00934102

Brief Title

Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses

Acronym

QUINCE

Official Title

Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (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

5. Study Description

Brief Summary

The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.

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

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lotrafilcon A

Arm Type

Active Comparator

Arm Description

Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Arm Title

Narafilcon A

Arm Type

Active Comparator

Arm Description

Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Arm Title

Galyfilcon A

Arm Type

Active Comparator

Arm Description

Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Intervention Type

Device

Intervention Name(s)

Narafilcon A contact lens

Intervention Description

Investigational, silicone hydrogel, spherical soft contact lens

Intervention Type

Device

Intervention Name(s)

Lotrafilcon A contact lens

Intervention Description

Commercially marketed, silicone hydrogel, spherical soft contact lens

Intervention Type

Device

Intervention Name(s)

Galyfilcon A contact lens

Intervention Description

Commercially marketed, silicone hydrogel, spherical soft contact lens

Primary Outcome Measure Information:

Title

Front Surface Lens Deposits

Description

Time Frame

Period 2, Day 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction Has had an ocular examination in the last two years Is a current soft (hydrogel or silicone hydrogel) contact lens wearer Has clear corneas and no active ocular disease Can be successfully fit with the lenses to be used in the study Other protocol-defined inclusion/exclusion criteria may apply Exclusion Criteria: Is pregnant or lactating Has undergone corneal refractive surgery Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study Other protocol-defined inclusion/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

Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses

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