Ametropia, Astigmatism, Presbyopia
Conditions
Brief summary
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population.
Detailed description
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population after 2 hours of wear.
Interventions
DEVICEcomfilcon A Sphere lens
2 hours of wear
DEVICEcomfilcon A Toric lens
2 hours of wear
DEVICEcomfilcon A Multifocal lens
2 hours of wear
2 hours of wear
DEVICEcomfilcon A Energys lens
2 hours of wear
Sponsors
Centre for Ocular Research & Education, Canada
CooperVision International Limited (CVIL)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 8 to 75 years (inclusive). 2. Current wearer of the Comfilcon A sphere, toric, multifocal, toric multifocal or Energys contact lens for at least 12 months. 3. At least occasional overnight wear in the last 12 months.
Exclusion criteria
1\. Current participation in a contact lens or contact lens care product clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Performance (Visual Acuity) | At the end of 2 hours of wear | Visual Performance will be measured using logMAR * High contrast, high illumination distance VA * High contrast, high illumination near VA |
| Incidence of contact lens-related adverse events | At the end of 2 hours of wear | Incidence of contact lens-related adverse events will be recorded from subjects |
Countries
United States
Contacts
Primary ContactJose A Vega, OD,MSc,PhD
Backup ContactJill Woods, MSc,MCOptom
Outcome results
None listed