Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.

Official Title
-----------------
SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers

Conditions
-----------------
Symptomatic Contact Lens Wearers

Intervention / Treatment
-----------------
* Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
* Device: renu fresh Multi-Purpose Solution (MPS)
* Device: Contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night). Vision correctable to 20/30 or better with contact lenses. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Sensitivity to multi-purpose solutions. Use of any topical ocular OTC or prescribed topical ocular medications. History (6 months) or current ocular infections or ocular inflammatory events. Ocular surgery within the past year. Medical condition or use of medications that cause ocular side effects. Participation in any investigational study within the past 30 days. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcon MPDS<br>MPDS used for 30 days as specified in protocol for contact lens care. | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)<br>* Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.<br>Device: Contact lenses<br>* Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.<br>|
| Active Comparator: renu fresh MPS<br>MPS used for 30 days as indicated for contact lens care. | Device: renu fresh Multi-Purpose Solution (MPS)<br>* Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.<br>* Other names: renu® fresh™ Multi-Purpose Solution;Device: Contact lenses<br>* Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses. | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening. | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. | Day 30 | 
| Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses. | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. | Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symptomatic, Contact lens care, Multi-purpose solution