Corneal and Conjunctival Sensitivity and Staining Study
Optifree RepleniSH Multipurpose Disinfecting Solution
+ ReNu Multiplus Multipurpose Solution
Eye Diseases+1
+ Hyperopia
+ Myopia
Treatment Study
Summary
Study start date: March 1, 2007
Actual date on which the first participant was enrolled.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. Observations will be made to monitor physiology.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 17 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. * Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Centre for Contact Lens Research, School of Optometry
Waterloo, CanadaOpen Centre for Contact Lens Research, School of Optometry in Google Maps