Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers
1 other identifier
interventional
63
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 18, 2009
CompletedFirst Posted
Study publicly available on registry
December 21, 2009
CompletedResults Posted
Study results publicly available
October 19, 2010
CompletedJuly 10, 2012
January 1, 2012
2 months
December 18, 2009
September 27, 2010
June 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Lens Awareness
Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.
4 weeks of wear
Study Arms (2)
Nelfilcon A
EXPERIMENTALNelfilcon A contact lens
Narafilcon A
ACTIVE COMPARATORNarafilcon A contact lens
Interventions
Daily disposable contact lens worn in a daily wear, daily disposable mode
Daily disposable contact lens worn in a daily wear, daily disposable mode
Eligibility Criteria
You may qualify if:
- Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
- Habitually wear lenses for at least 8 hours per day and 4 days per week.
- Report 2 or more qualifying symptoms with current contact lenses.
- Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.
You may not qualify if:
- Eye injury or surgery within twelve weeks immediately prior to enrollment.
- Currently enrolled in any clinical trial.
- Any use of ocular medications, exclusive of contact lens rewetting drops.
- History of corneal or refractive surgery.
- Cylinder correction greater than 1.00 D
- Current monovision contact lens wearers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CIBA VISIONlead
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
December 18, 2009
First Posted
December 21, 2009
Study Start
September 1, 2009
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
July 10, 2012
Results First Posted
October 19, 2010
Record last verified: 2012-01