A Study to Evaluate 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.
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
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 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
November 24, 2014
CompletedNovember 24, 2014
November 1, 2014
1 month
March 4, 2011
November 4, 2014
November 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Distance High Contrast logMAR Visual Acuity at 1 Week
Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week
Baseline & 1 week
Secondary Outcomes (2)
Slit Lamp Findings ≥ Grade 2
1 week
Overall Comfort
1 week
Study Arms (2)
Investigational Lens
EXPERIMENTALBausch \& Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.
Air Optix Aqua Lens
ACTIVE COMPARATORCiba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.
Interventions
Lenses worn on a daily wear basis for one week
Lenses worn on a daily wear basis for one week
Eligibility Criteria
You may qualify if:
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.
You may not qualify if:
- 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
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
Robert Steffen, OD, MS
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
January 1, 2011
Study Completion
February 1, 2011
Last Updated
November 24, 2014
Results First Posted
November 24, 2014
Record last verified: 2014-11