Evaluation of the Performance of Non-molded Soft Contact Lenses
1 other identifier
interventional
38
1 country
1
Brief Summary
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.
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 2006
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, 2006
CompletedFirst Submitted
Initial submission to the registry
September 1, 2006
CompletedFirst Posted
Study publicly available on registry
September 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
December 13, 2010
CompletedJanuary 10, 2011
January 1, 2011
1.3 years
September 1, 2006
November 8, 2010
January 5, 2011
Conditions
Outcome Measures
Primary Outcomes (4)
Visual Acuity
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
baseline
Visual Acuity
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
9 month
Neovascularisation
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
baseline
Neovascularization
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
9 month
Study Arms (2)
soft contact lens
EXPERIMENTALnon-lens wear
NO INTERVENTIONcontrol group
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, good health, age \>17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood \& signed consent form.
You may not qualify if:
- Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Waterloolead
- CIBA VISIONcollaborator
Study Sites (1)
Centre for Contact Lens Research, University of Waterloo,
Waterloo, Ontario, N2L 3G1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Craig Woods
- Organization
- Centre for Contact Lens Research
Study Officials
- PRINCIPAL INVESTIGATOR
Desmond Fonn
Centre for Contact Lens Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 1, 2006
First Posted
September 4, 2006
Study Start
August 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
January 10, 2011
Results First Posted
December 13, 2010
Record last verified: 2011-01