Daily Disposable Toric Comparative Trial in Europe
1 other identifier
interventional
220
0 countries
N/A
Brief Summary
The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 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
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
March 24, 2011
CompletedDecember 13, 2013
January 1, 2012
2 months
February 16, 2010
February 25, 2011
November 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Comfort
Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.
1 week of wear
Study Arms (2)
nelfilcon A / ocufilcon D
OTHERNelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
ocufilcon D / nelfilcon A
OTHEROcufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Interventions
Commercially marketed, toric, soft contact lens for daily disposable wear
Commercially marketed, toric, soft contact lens for daily disposable wear
Eligibility Criteria
You may qualify if:
- Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
- Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
- Achieve acceptable or optimal fit in each eye at time of dispense.
You may not qualify if:
- Habitual daily disposable contact lens wearer.
- Sleeps in contact lenses overnight.
- Currently enrolled in an ophthalmic clinical trial.
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
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 18, 2010
Study Start
January 1, 2010
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
December 13, 2013
Results First Posted
March 24, 2011
Record last verified: 2012-01