Clinical Evaluation of Two Daily Disposable Lenses in Neophytes
1 other identifier
interventional
326
1 country
1
Brief Summary
The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2009
Shorter than P25 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
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 29, 2009
CompletedFirst Posted
Study publicly available on registry
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
January 13, 2011
CompletedJuly 10, 2012
January 1, 2012
4 months
September 29, 2009
December 17, 2010
June 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Lens Satisfaction
Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent
1 week
Study Arms (2)
nelfilcon A
EXPERIMENTALCommercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
narafilcon A
ACTIVE COMPARATORCommercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Interventions
Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.
Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.
Eligibility Criteria
You may qualify if:
- No previous contact lens experience or attempts to try contact lenses (neophytes).
- Currently wearing spectacles or needing vision correction in both eyes.
- No older than 45 years of age.
- Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
- Interested in wearing contact lenses.
- Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
You may not qualify if:
- Eye injury or surgery within twelve weeks prior to enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Previous corneal or refractive surgery.
- Currently enrolled in any Clinical Trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CIBA VISIONlead
Study Sites (1)
The Research Intelligence Group (TRiG)
Fort Washington, Pennsylvania, 19034, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
- 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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2009
First Posted
October 1, 2009
Study Start
August 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
July 10, 2012
Results First Posted
January 13, 2011
Record last verified: 2012-01