Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers
1 other identifier
interventional
278
1 country
1
Brief Summary
The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
June 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedSeptember 10, 2012
September 1, 2012
3 years
June 25, 2009
September 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Corneal Staining
2 hours
Secondary Outcomes (1)
Subjective Comfort
2 hours
Study Arms (5)
Contact lens solution #1
EXPERIMENTALContact lens solution #2
EXPERIMENTALContact lens solution #3
EXPERIMENTALContact lens solution #4
EXPERIMENTALSaline/blister pack solution
ACTIVE COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Visioncare Research, Ltd.
Farnham, Surrey, GU9 7EN, United Kingdom
Related Publications (1)
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.
PMID: 25070393DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2009
First Posted
June 29, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
September 10, 2012
Record last verified: 2012-09