Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period
1 other identifier
interventional
213
0 countries
N/A
Brief Summary
The purpose of this trial is to compare two different contact lenses during 4 weeks 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
CompletedFirst Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
October 1, 2010
CompletedDecember 5, 2023
January 1, 2012
2 months
December 17, 2008
July 23, 2010
November 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Comfort at End of Day
Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.
After 4 weeks of wear
Study Arms (2)
Lotrafilcon A
EXPERIMENTALInvestigational, spherical, silicone hydrogel contact lenses
Comfilcon A
ACTIVE COMPARATORCommercially marketed, spherical, silicone hydrogel contact lenses
Interventions
Eligibility Criteria
You may qualify if:
- Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
- Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
- Replace 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
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
- Current soft toric lens wearers
- Those who dispose of their soft lenses on a daily basis
- Current NIGHT \& DAY® or Biofinity® 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 18, 2008
Study Start
November 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
December 5, 2023
Results First Posted
October 1, 2010
Record last verified: 2012-01