Back to resultsClear Care® Plus vs. PeroxiClear™
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clear Care Plus contact lens solution
PeroxiClear contact lens solution
Silicone hydrogel contact lenses
Sponsored by
About this trial
This is an interventional supportive care trial for Refractive Error focused on measuring Contact lens solution
Eligibility Criteria
Inclusion Criteria:
- Sign informed consent form;
- Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);
- Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;
- Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Current hydrogen peroxide-based solution user;
- Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Clear Care Plus, then PeroxiClear
PeroxiClear, then Clear Care Plus
Arm Description
Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
Outcomes
Primary Outcome Measures
Mean Residual Peroxide at Day 30
The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
Secondary Outcome Measures
Mean Osmolality in Lens Cases at Day 30
The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02413333
Brief Title
Clear Care® Plus vs. PeroxiClear™
Official Title
Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (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 evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.
Detailed Description
Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
Contact lens solution
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clear Care Plus, then PeroxiClear
Arm Type
Other
Arm Description
Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
Arm Title
PeroxiClear, then Clear Care Plus
Arm Type
Other
Arm Description
PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
Intervention Type
Device
Intervention Name(s)
Clear Care Plus contact lens solution
Other Intervention Name(s)
Clear Care Plus
Intervention Description
3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses
Intervention Type
Device
Intervention Name(s)
PeroxiClear contact lens solution
Other Intervention Name(s)
PeroxiClear
Intervention Description
3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses
Intervention Type
Device
Intervention Name(s)
Silicone hydrogel contact lenses
Intervention Description
2-week/monthly replacement contact lenses per participant's habitual brand
Primary Outcome Measure Information:
Title
Mean Residual Peroxide at Day 30
Description
The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
Time Frame
Day 30, each product
Secondary Outcome Measure Information:
Title
Mean Osmolality in Lens Cases at Day 30
Description
The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
Time Frame
Day 30, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign informed consent form;
Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);
Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;
Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Current hydrogen peroxide-based solution user;
Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;
Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;
Use of systemic or ocular medications for which contact lens wear could be contraindicated;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, Vision Care, Global Medical Affairs
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Clear Care® Plus vs. PeroxiClear™
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