- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00929487
Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers
September 6, 2012 updated by: Alcon Research
Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers
The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
278
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Surrey
-
Farnham, Surrey, United Kingdom, GU9 7EN
- Visioncare Research, Ltd.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contact lens solution #1
|
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.
Other Names:
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.
Other Names:
|
Experimental: Contact lens solution #2
|
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.
Other Names:
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.
Other Names:
|
Experimental: Contact lens solution #3
|
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.
Other Names:
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.
Other Names:
|
Experimental: Contact lens solution #4
|
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.
Other Names:
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.
Other Names:
|
Active Comparator: Saline/blister pack solution
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Corneal Staining
Time Frame: 2 hours
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective Comfort
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
June 25, 2009
First Submitted That Met QC Criteria
June 26, 2009
First Posted (Estimate)
June 29, 2009
Study Record Updates
Last Update Posted (Estimate)
September 10, 2012
Last Update Submitted That Met QC Criteria
September 6, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMA-09-14/RDG-11-152
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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