Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses
QUINCE
1 other identifier
interventional
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
December 1, 2010
CompletedJuly 10, 2012
November 1, 2010
1 month
July 6, 2009
November 1, 2010
June 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Period 2, Day 6
Study Arms (3)
Lotrafilcon A
ACTIVE COMPARATORLotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
Narafilcon A
ACTIVE COMPARATORNarafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
Galyfilcon A
ACTIVE COMPARATORGalyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
Interventions
Investigational, silicone hydrogel, spherical soft contact lens
Commercially marketed, silicone hydrogel, spherical soft contact lens
Commercially marketed, silicone hydrogel, spherical soft contact lens
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CIBA VISIONlead
- University of Waterloocollaborator
Study Sites (1)
Centre for Contact Lens Research: University of Waterloo
Waterloo, Ontario, N2L 3G1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Craig Woods, PhD, FAAO / Research Manager
- Organization
- University of Waterloo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2009
First Posted
July 8, 2009
Study Start
August 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
July 10, 2012
Results First Posted
December 1, 2010
Record last verified: 2010-11