Back to resultsAcute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Contact lens multi-purpose solution
Saline/blister pack solution
Contact lenses
Sponsored by
About this trial
This is an interventional supportive care trial for Myopia focused on measuring contact lens wear, contact lens solution, corneal staining
Eligibility Criteria
Inclusion Criteria:
- Have read, understood, signed, and dated the written Informed Consent.
- Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
- Vision correctable to at least 20/30 Snellen.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Topical ocular medication use.
- History of hypersensitivity to any component of the study contact lens care systems.
- Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
- Pregnant, lactating, or planning a pregnancy.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Visioncare Research, Ltd.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Contact lens solution #1
Contact lens solution #2
Contact lens solution #3
Contact lens solution #4
Saline/blister pack solution
Arm Description
Outcomes
Primary Outcome Measures
Corneal Staining
Secondary Outcome Measures
Subjective Comfort
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00929487
Brief Title
Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers
Official Title
Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (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 clinically evaluate lens care solutions used with soft contact lenses.
Detailed Description
This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
contact lens wear, contact lens solution, corneal staining
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contact lens solution #1
Arm Type
Experimental
Arm Title
Contact lens solution #2
Arm Type
Experimental
Arm Title
Contact lens solution #3
Arm Type
Experimental
Arm Title
Contact lens solution #4
Arm Type
Experimental
Arm Title
Saline/blister pack solution
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Contact lens multi-purpose solution
Other Intervention Name(s)
ReNu Multiplus, Ote Hydroshield, Sauflon Synergi, Lapis Lazuli Eye See Aqua Balance, Avizor All Clean Soft, Sauflon Cyclean, Vita Research Regard, Menicon MeniCare Soft, ALL, ReNu MPS, Welcon, Hydron
Intervention Description
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Intervention Type
Other
Intervention Name(s)
Saline/blister pack solution
Other Intervention Name(s)
AMO OcuPure Saline, Saline
Intervention Description
A fresh pair of contact lenses was soaked overnight in saline prior to study visit or was inserted directly from the blister pack, then worn for two hours on the day of the study visit.
Intervention Type
Device
Intervention Name(s)
Contact lenses
Other Intervention Name(s)
PureVision, Air Optix Aqua, Acuvue Advance, Biofinity
Intervention Description
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Primary Outcome Measure Information:
Title
Corneal Staining
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Subjective Comfort
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have read, understood, signed, and dated the written Informed Consent.
Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
Vision correctable to at least 20/30 Snellen.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Topical ocular medication use.
History of hypersensitivity to any component of the study contact lens care systems.
Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
Pregnant, lactating, or planning a pregnancy.
Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Visioncare Research, Ltd.
City
Farnham
State/Province
Surrey
ZIP/Postal Code
GU9 7EN
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25070393
Citation
Malet F. An acute clinical comparison of corneal staining and comfort associated with contact lens care solutions. Cont Lens Anterior Eye. 2014 Oct;37(5):351-7. doi: 10.1016/j.clae.2014.05.007. Epub 2014 Jul 26.
Results Reference
derived
Learn more about this trial
Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers
We'll reach out to this number within 24 hrs