Corneal and Conjunctival Sensitivity and Staining Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Title
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Corneal and Conjunctival Sensitivity and Staining Study

Conditions
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Myopia, Hyperopia

Intervention / Treatment
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* Drug: Optifree RepleniSH Multipurpose Disinfecting Solution
* Drug: ReNu Multiplus Multipurpose Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Optifree RepleniSH Multipurpose Disinfecting Solution<br> | Drug: Optifree RepleniSH Multipurpose Disinfecting Solution<br>* lens care system<br>* Other names: lens care system;|
| Active Comparator: ReNu Multiplus Multipurpose Solution<br> | Drug: ReNu Multiplus Multipurpose Solution<br>* lens care system<br>* Other names: lens care system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining Grade | A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area). | baseline | 
| Corneal Staining Grade | A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area). | day 7 |