Corneal and Conjunctival Sensitivity and Staining Study
1 other identifier
interventional
50
1 country
1
Brief Summary
The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 23, 2007
CompletedFirst Posted
Study publicly available on registry
April 3, 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
July 12, 2010
CompletedJuly 12, 2010
June 1, 2010
1.8 years
March 23, 2007
January 5, 2010
June 9, 2010
Conditions
Outcome Measures
Primary Outcomes (4)
Corneal Sensitivity
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
baseline
Corneal Sensitivity
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
day 7
Conjunctival Sensitivity
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
baseline
Conjunctival Sensitivity
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
day 7
Secondary Outcomes (2)
Corneal Staining Grade
baseline
Corneal Staining Grade
day 7
Study Arms (2)
Optifree RepleniSH Multipurpose Disinfecting Solution
ACTIVE COMPARATORReNu Multiplus Multipurpose Solution
ACTIVE COMPARATORInterventions
lens care system
lens care system
Eligibility Criteria
You may qualify if:
- An eligible participant is one who:
- Is between 17-45 years old and has full legal capacity to volunteer.
- Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)
- Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.
- Has normal binocular vision (no strabismus, no amblyopia).
- Has clear corneas and no active ocular disease.
- Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.
- Has astigmatism less than or equal to -1.00DC.
- Agrees to wear the study lenses on a daily wear basis.
- Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study.
You may not qualify if:
- A person is ineligible if he/she:
- 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 a known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- Is pregnant or lactating.
- Is participating in any other clinical or research study.
- Has a known clinically significant sensitivity to the contact lens care solutions used in the study.
- Has ocular or systemic allergies that could adversely affect contact lens wear.
- Currently wears lenses on a continuous or extended wear basis.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
- Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear inadvisable.
- Is a rigid lens wearer.
- +1 more criteria
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
Waterloo, Ontario, N2L 3G1, Canada
Related Publications (1)
Situ P, Simpson TL, Jones LW, Fonn D. Effects of silicone hydrogel contact lens wear on ocular surface sensitivity to tactile, pneumatic mechanical, and chemical stimulation. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6111-7. doi: 10.1167/iovs.09-4807. Epub 2010 Jun 30.
PMID: 20592230DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Sample size completed as anticipated.
Results Point of Contact
- Title
- Dr Craig A Woods
- Organization
- CCLR
Study Officials
- PRINCIPAL INVESTIGATOR
Desmond Fonn, M.Optom
University of Waterloo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 23, 2007
First Posted
April 3, 2007
Study Start
March 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
July 12, 2010
Results First Posted
July 12, 2010
Record last verified: 2010-06