Completed

Corneal and Conjunctival Sensitivity and Staining Study

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What is being tested

Optifree RepleniSH Multipurpose Disinfecting Solution

+ ReNu Multiplus Multipurpose Solution

Drug
Who is being recruted

Eye Diseases+1

+ Hyperopia

+ Myopia

From 17 to 45 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: March 2007
See protocol details

Summary

Principal SponsorUniversity of Waterloo
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleCorneal and Conjunctival Sensitivity and Staining Study
NCT00455455
Principal SponsorUniversity of Waterloo
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Eye DiseasesHyperopiaMyopiaRefractive Errors

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Study 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

Suspended

Centre for Contact Lens Research, School of Optometry

Waterloo, CanadaOpen Centre for Contact Lens Research, School of Optometry in Google Maps
CompletedOne Study Center