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Fort Worth, Texas, 76134, United States
Completed
NCT Number: NCT01187355
Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers
The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
- Vision correctable to 20/30 or better with contact lenses.
- Other protocol-defined inclusion criteria may apply.
Exclusion criteria
- Sensitivity to multi-purpose solutions.
- Use of any topical ocular OTC or prescribed topical ocular medications.
- History (6 months) or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- Medical condition or use of medications that cause ocular side effects.
- Participation in any investigational study within the past 30 days.
- Other protocol-defined exclusion criteria may apply.
Treatment and study plan
FID 114675A multi-purpose disinfecting solution (MPDS)
DeviceInvestigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.
renu fresh Multi-Purpose Solution (MPS)
DeviceCommercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.
Other names: renu® fresh™ Multi-Purpose Solution
Contact Lenses
DeviceContact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.
Primary outcomes
-
Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.
Time frame: Day 30
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Secondary outcomes
-
Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.
Time frame: Day 30
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
-
Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.
Time frame: Day 30
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Sponsors and collaborators
Lead sponsor
Alcon Research
Industry
Registry information
Official study title
SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Aug 24, 2010
- Registry last updated
- Jul 30, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.