Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
1 other identifier
interventional
196
0 countries
N/A
Brief Summary
The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2008
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
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 11, 2008
CompletedFirst Posted
Study publicly available on registry
December 16, 2008
CompletedResults Posted
Study results publicly available
October 4, 2010
CompletedJune 29, 2012
January 1, 2012
1 month
December 11, 2008
June 18, 2010
June 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Comfort After Insertion
Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.
30-60 seconds after initial insertion
Study Arms (2)
Senofilcon A / Lotrafilcon A
OTHERSenofilcon A, followed by Lotrafilcon A
Lotrafilcon A / Senofilcon A
OTHERLotrafilcon A, followed by Senofilcon A
Interventions
Investigational, silicone hydrogel, spherical, soft contact lens
Commercially marketed, silicone hydrogel, spherical, soft contact lens
Eligibility Criteria
You may qualify if:
- Currently wearing soft contact lenses
- Replaces lenses on a weekly or longer schedule
You may not qualify if:
- Requires concurrent ocular medication
- Eye injury or surgery within twelve weeks immediately prior to enrollment
- Currently wearing soft toric lens wearers
- Those who dispose of their soft lenses on a daily basis
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2008
First Posted
December 16, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
June 29, 2012
Results First Posted
October 4, 2010
Record last verified: 2012-01