Back to resultsEffectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydrogen peroxide-based contact lens solution
Habitual contact lens solution
Habitual contact lenses
Sponsored by
About this trial
This is an interventional supportive care trial for Refractive Error focused on measuring Silicone hydrogel contact lenses, Multi-purpose solution, Lid Papillae, Palpebral Roughness
Eligibility Criteria
Inclusion Criteria:
- Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
- Symptoms of contact lens discomfort as defined by the protocol.
- Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
- Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Extended (over-night) contact lens wearer.
- Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clear Care
Habitual MPS
Arm Description
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
Habitual contact lens solution used with habitual contact lenses for 90 days
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.
Secondary Outcome Measures
Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90
As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses.
Mean Frequency Score for Symptoms of Grittiness at Day 90
As interpreted and reported by the subject on a questionnaire. The subject was asked, "During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses?" and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly).
Mean Frequency Score for Symptoms of Dryness at Day 90
As reported and interpreted by the subject on a questionnaire. The subject was asked "During a typical day in the past 2 weeks, how often did your eyes feel dry?" and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01996709
Brief Title
Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
Official Title
Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (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 is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
Silicone hydrogel contact lenses, Multi-purpose solution, Lid Papillae, Palpebral Roughness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clear Care
Arm Type
Experimental
Arm Description
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
Arm Title
Habitual MPS
Arm Type
Active Comparator
Arm Description
Habitual contact lens solution used with habitual contact lenses for 90 days
Intervention Type
Device
Intervention Name(s)
Hydrogen peroxide-based contact lens solution
Other Intervention Name(s)
Clear Care®
Intervention Type
Device
Intervention Name(s)
Habitual contact lens solution
Intervention Description
Biguanide-preserved
Intervention Type
Device
Intervention Name(s)
Habitual contact lenses
Intervention Description
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
Description
Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.
Time Frame
Baseline (Day 0), Day 90
Secondary Outcome Measure Information:
Title
Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90
Description
As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses.
Time Frame
Day 90
Title
Mean Frequency Score for Symptoms of Grittiness at Day 90
Description
As interpreted and reported by the subject on a questionnaire. The subject was asked, "During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses?" and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly).
Time Frame
Day 90
Title
Mean Frequency Score for Symptoms of Dryness at Day 90
Description
As reported and interpreted by the subject on a questionnaire. The subject was asked "During a typical day in the past 2 weeks, how often did your eyes feel dry?" and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly).
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
Symptoms of contact lens discomfort as defined by the protocol.
Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Extended (over-night) contact lens wearer.
Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Zoota, MPH
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
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