Evaluation of a New Silicone Hydrogel Contact Lens
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
1 other identifier
interventional
66
1 country
1
Brief Summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.
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 Dec 2010
Shorter than P25 for not_applicable
1 active site
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
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 4, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedResults Posted
Study results publicly available
February 23, 2015
CompletedFebruary 23, 2015
February 1, 2015
Same day
March 4, 2011
March 31, 2014
February 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Acuity
Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.
Dispensing & 1-week follow up
Secondary Outcomes (2)
Slit Lamp Findings
1 week
Comfort
1 Weeks
Study Arms (2)
Air Optix Aqua
ACTIVE COMPARATORCiba Vision daily wear contact lens
Test Lens
EXPERIMENTALInvestigational silicone hydrogel contact lens
Interventions
Eligibility Criteria
You may qualify if:
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
You may not qualify if:
- Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- An active ocular disease, any corneal infiltrative response or are using any ocular medications.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Allergic to any component in the study care products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb, Incorporated
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert Steffen
- Organization
- Bausch & Lomb
Study Officials
- STUDY DIRECTOR
Beverly Barna
Bausch & Lomb Incorporated
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
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2011
First Posted
March 7, 2011
Study Start
December 1, 2010
Primary Completion
December 1, 2010
Study Completion
January 1, 2011
Last Updated
February 23, 2015
Results First Posted
February 23, 2015
Record last verified: 2015-02