Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2010
Shorter than P25 for not_applicable
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
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 3, 2010
CompletedResults Posted
Study results publicly available
September 8, 2011
CompletedJuly 10, 2012
January 1, 2012
1 month
November 1, 2010
August 5, 2011
June 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Vision Quality
Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
1 week of wear
Study Arms (2)
Nelfilcon A / Narafilcon B
OTHERNelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Narafilcon B / Nelfilcon A
OTHERNarafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Interventions
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
Eligibility Criteria
You may qualify if:
- Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
- Able to wear study lenses in the available powers from -1.00D to -6.00D.
You may not qualify if:
- Eye injury within twelve weeks of enrollment.
- History of corneal or refractive surgery.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.
- Monovision correction during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CIBA VISIONlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management
- Organization
- CIBA VISION
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2010
First Posted
November 3, 2010
Study Start
October 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
July 10, 2012
Results First Posted
September 8, 2011
Record last verified: 2012-01