Vision Correction
Conditions
Brief summary
The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).
Detailed description
The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.
Interventions
DEVICEDefinitive Contact Lens
Daily wear contact lens
DEVICEBiofinity
Daily wear contact lens
Sponsors
Contamac Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* existing contact lens wearer * read and signed statement of informed consent * has clear central cornea * requires spherical distance correction
Exclusion criteria
* has worn RGP contact lenses within the last 30 days * is using any ocular medication * has had refractive surgery * has an infectious disease * is pregnant or lactating * is participating in another clinical research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy. | 3 months | The clinical study will assess the following performance variables as compared to the predicate device during 5 follow-up visits over a 3 month period to demonstrate safety and efficacy: Sphere-cyl Refraction and VA, Keratometry, Comfort, Handling, Symptoms, Over-Refraction and VA, Lens Fit, Lens Deposits, and Slit Lamp Findings. |
Countries
United Kingdom
Outcome results
None listed