Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2007
Shorter than P25 for phase_3
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
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 21, 2007
CompletedFirst Posted
Study publicly available on registry
August 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
September 16, 2010
CompletedSeptember 16, 2010
August 1, 2010
1.3 years
August 21, 2007
March 26, 2010
August 20, 2010
Conditions
Outcome Measures
Primary Outcomes (4)
High Contrast Visual Acuity
High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
2 weeks
Low Contrast Visual Acuity
Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
2 weeks
In-vivo Wettability
Pre-lens non-invasive tear breakup time
2 weeks
Subjective Comfort Rating
Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.
2 weeks
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Is at least 17 years of age and has full legal capacity to volunteer.
- Has read, understood and signed an information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is presently using either bi-weekly or monthly replacement lenses.
- Has symptoms of ocular dryness as determined by specific pre-screening criteria.
- Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
- Has clear corneas and no active ocular disease.
- Has had an ocular examination in the last two years.
You may not qualify if:
- A person will be excluded from the study if he/she:
- Is an asymptomatic lens wearer.
- Is a daily disposable contact lens wearer.
- Is a current extended wear contact lens wearer.
- Currently uses one of the study lens care regimens.
- Has any clinically significant blepharitis.
- Has undergone corneal refractive surgery.
- Is aphakic.
- Has any active ocular disease.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that may affect ocular health.
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- Is participating in any other type of clinical or research study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Waterloolead
- Alcon Researchcollaborator
Study Sites (1)
Centre for Contact Lens Research, School of Optometry, University of Waterloo.
Waterloo, Ontario, N2L3G1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Craig A Woods, Research Manager
- Organization
- Centre for Contact Lens Research
Study Officials
- PRINCIPAL INVESTIGATOR
Desmond Fonn, M. Optom
University of Waterloo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 21, 2007
First Posted
August 24, 2007
Study Start
August 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
September 16, 2010
Results First Posted
September 16, 2010
Record last verified: 2010-08