Evaluation of the Feasibility 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 an investigational contact lens.
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
October 22, 2020
CompletedOctober 22, 2020
September 1, 2020
1 month
March 4, 2011
August 21, 2020
September 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
At 1 week follow up
Secondary Outcomes (2)
Percentage of Eyes With > Grade 2 Slit Lamp Findings
At 1 week follow up
Symptoms and Complaints
At 1 week follow up
Study Arms (2)
Investigational lens
EXPERIMENTALBausch \& Lomb investigational silicone hydrogel lens
Air Optix Aqua lens
ACTIVE COMPARATORCiba Vision Air Optix Aqua contact lens
Interventions
Bausch \& Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.
Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.
Eligibility Criteria
You may qualify if:
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Be myopic and require lens correction in each eye.
- 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:
- 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
- Study Director
- Organization
- Bausch Health
Study Officials
- PRINCIPAL INVESTIGATOR
Tara Vaz, OD
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
- Purpose
- OTHER
- 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
October 22, 2020
Results First Posted
October 22, 2020
Record last verified: 2020-09