Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution (MPDS) compared to Biotrue™ Multipurpose Solution (MPS) in silicone hydrogel contact lens wearers.

Detailed Description
-----------------
In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution or Biotrue™ Multipurpose Solution in Period 1 for use with their habitual contact lenses, after which they switched to the alternate solution in Period 2. Each period was 30 days in length. A 2-day washout period during which participants refrained from using a multi-purpose contact lens solution preceded Period 1 and Period 2.

Official Title
-----------------
Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1

Conditions
-----------------
Myopia, Hyperopia, Contact Lens Comfort

Intervention / Treatment
-----------------
* Device: Opti-Free® PureMoist® MPDS
* Device: Biotrue™ MPS
* Device: Habitual contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least one month prior to Visit 1; Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on two days during the study; Must have habitually used a Biguanide preserved multi-purpose solution (other than Biotrue) for at least 30 days prior to Visit 1; Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1; Have access, capability and willingness to review and answer text messages; Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment; Willing to follow the study procedures and visit schedule; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Need to wear lenses on an extended wear (i.e. overnight) basis during the study; Known sensitivity or intolerance to Biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products; Monocular (only one eye with functional vision) or fit with only one lens; Wearing toric or multifocal contact lenses or fit with monovision; Use of additional lens care products other than a Biguanide preserved multipurpose solution such as daily or enzyme cleaners within the one week prior to Visit 1; Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1; Abnormal ocular condition observed during the Visit 1 slit-lamp examination; Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1; Ocular surgery within the 12 months prior to Visit 1; Participation in any other clinical trial within 30 days of enrollment; 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PureMoist - Biotrue<br>Opti-Free® PureMoist® MPDS used first, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses. | Device: Opti-Free® PureMoist® MPDS<br> <br> * Other names: OPTI-FREE® PureMoist™;Device: Biotrue™ MPS<br> <br> * Other names: Biotrue™;Device: Habitual contact lenses<br>* Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.<br>|
| Other: Biotrue - PureMoist<br>Biotrue™ MPS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses. | Device: Opti-Free® PureMoist® MPDS<br> <br> * Other names: OPTI-FREE® PureMoist™;Device: Biotrue™ MPS<br> <br> * Other names: Biotrue™;Device: Habitual contact lenses<br>* Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining | Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed. | Day 30 | 
| Change From Baseline in Corneal Staining at Day 30 | Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed. | Baseline (Day 0), Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biotrue, multi-purpose solution, silicone hydrogel, contact lenses, comfort, Opti-Free