Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 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 22, 2008
CompletedFirst Posted
Study publicly available on registry
December 23, 2008
CompletedResults Posted
Study results publicly available
October 29, 2010
CompletedMay 26, 2023
May 1, 2023
1 month
December 22, 2008
September 3, 2010
May 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Vision
Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.
1 week
Study Arms (2)
Experimental Lotrafilcon A Contact Lens
EXPERIMENTALLotrafilcon A experimental contact lens randomly assigned to one eye
Commercial Lotrafilcon A Contact Lens
ACTIVE COMPARATORLotrafilcon A commercial contact lens randomly assigned to one eye
Interventions
Experimental spherical, silicone hydrogel soft contact lens
Commercially marketed spherical, silicone hydrogel soft contact lens
Eligibility Criteria
You may qualify if:
- Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day
- On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses
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
- Any active corneal infection
- Any use of medications for which contact lens wear would be contraindicated
- History of corneal refractive surgery
- Wears toric contact lenses
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
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2008
First Posted
December 23, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
May 26, 2023
Results First Posted
October 29, 2010
Record last verified: 2023-05