Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

Study Overview
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Brief Summary
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An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Conditions
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Corneal Staining

Intervention / Treatment
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* Device: Biotrue MPS
* Device: Investigational MPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: were at least 18 years old; were experienced contact lens wearers; were correctable to at least 20/40 or better in both eyes with contact lenses; were in good general health, with healthy eyes (other than requiring vision correction); had not worn lenses for at least 12 hours before each baseline visit; had a corneal staining score no greater than Grade 1 in either eye at time of enrollment; had previously used an MPS or hydrogen peroxide solution successfully. Exclusion Criteria: had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition; required concurrent ocular medication or have used ocular medication within 24 hours of entering the study; had a known sensitivity or intolerance to any MPS, study products or ingredient(s); were currently participating in any other clinical study; had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biotrue MPS<br> | Device: Biotrue MPS<br>* Multi-purpose contact lens care solution<br>|
| Experimental: Investigational MPS<br> | Device: Investigational MPS<br>* Multi-purpose contact lens care solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining by Wear Time | All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens. | 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Solution Preference | All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference. | Day 4 | 
| Overall Ocular Comfort | All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt. | Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corneal staining and comfort evaluation in normal, habitual contact lens wearers.