Back to resultsEvaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2
Primary Purpose
Myopia, Hyperopia, Contact Lens Comfort
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Opti-Free® PureMoist® MPDS
RevitaLens MPDS
Habitual Contact Lenses
Sponsored by
About this trial
This is an interventional supportive care trial for Myopia focused on measuring multi-purpose solution, silicone hydrogel, contact lenses, comfort, Opti-Free, RevitaLens
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 1 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 2 days during the study;
- Must have habitually used a biguanide preserved multi-purpose solution (other than RevitaLens) 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 multi-purpose solution such as daily or enzyme cleaners within the 1 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
PureMoist - RevitaLens
RevitaLens - PureMoist
Arm Description
Opti-Free® PureMoist® MPDS used first, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
RevitaLens MPDS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
Outcomes
Primary Outcome Measures
Subjective Lens Wear Comfort
Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, "When I use this solution, I can comfortably wear my lenses," with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01684046
Brief Title
Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2
Official Title
Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.
Detailed Description
In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist MPDS or RevitaLens MPDS 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia, Contact Lens Comfort
Keywords
multi-purpose solution, silicone hydrogel, contact lenses, comfort, Opti-Free, RevitaLens
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PureMoist - RevitaLens
Arm Type
Other
Arm Description
Opti-Free® PureMoist® MPDS used first, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
Arm Title
RevitaLens - PureMoist
Arm Type
Other
Arm Description
RevitaLens MPDS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
Intervention Type
Device
Intervention Name(s)
Opti-Free® PureMoist® MPDS
Other Intervention Name(s)
OPTI-FREE® PureMoist®
Intervention Type
Device
Intervention Name(s)
RevitaLens MPDS
Other Intervention Name(s)
RevitaLens OcuTec®, COMPLETE® RevitaLens
Intervention Type
Device
Intervention Name(s)
Habitual Contact Lenses
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective Lens Wear Comfort
Description
Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, "When I use this solution, I can comfortably wear my lenses," with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 1 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 2 days during the study;
Must have habitually used a biguanide preserved multi-purpose solution (other than RevitaLens) 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 multi-purpose solution such as daily or enzyme cleaners within the 1 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessie Lemp, MS
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2
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