Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (QUINCE)
This study has been completed.
Sponsor:
CIBA VISION
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00934102
First received: July 6, 2009
Last updated: June 26, 2012
Last verified: November 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: Narafilcon A contact lens Device: Lotrafilcon A contact lens Device: Galyfilcon A contact lens |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C) |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Front Surface Lens Deposits [ Time Frame: Period 2, Day 6 ] [ Designated as safety issue: No ]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.
| Enrollment: | 57 |
| Study Start Date: | August 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Lotrafilcon A
Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
|
Device: Lotrafilcon A contact lens
Commercially marketed, silicone hydrogel, spherical soft contact lens
|
|
Active Comparator: Narafilcon A
Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
|
Device: Narafilcon A contact lens
Investigational, silicone hydrogel, spherical soft contact lens
|
|
Active Comparator: Galyfilcon A
Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
|
Device: Galyfilcon A contact lens
Commercially marketed, silicone hydrogel, spherical soft contact lens
|
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Alcon Research ( CIBA VISION ) |
| ClinicalTrials.gov Identifier: | NCT00934102 History of Changes |
| Other Study ID Numbers: | P-368-C-103 |
| Study First Received: | July 6, 2009 |
| Results First Received: | November 1, 2010 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on June 13, 2013