Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism
1 other identifier
interventional
95
0 countries
N/A
Brief Summary
The purpose of this trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.
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 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
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 21, 2010
CompletedFirst Posted
Study publicly available on registry
September 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
August 26, 2011
CompletedJuly 10, 2012
January 1, 2012
1 month
September 21, 2010
July 28, 2011
June 27, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of Vision (Crisp and Clear)
Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.
1 week of wear
Study Arms (2)
Nelfilcon A invest'l / nelfilconA comm'l
OTHERNelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
Nelfilcon A comm'l / nelfilconA invest'l
OTHERNelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
Interventions
Investigational, soft contact lens for astigmatism worn on a daily disposable basis.
Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.
Eligibility Criteria
You may qualify if:
- Currently wearing soft contact lenses with astigmatism correction
You may not qualify if:
- Eye injury or surgery within twelve weeks prior to enrollment
- Currently enrolled in an ophthalmic clinical trial
- Strabismus
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator
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
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2010
First Posted
September 23, 2010
Study Start
September 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
July 10, 2012
Results First Posted
August 26, 2011
Record last verified: 2012-01