Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens

Contamac

Status: Completed

Conditions: Vision Correction

Treatments: Device: Definitive Contact Lens; Device: Biofinity

Study type: Interventional

Funder types: Industry

Identifiers

NCT01197859

CCSH-1901

Details and patient eligibility

About

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).

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups, including a placebo group

Contamac 74% silicone hydrogel contact lens

Active Comparator group

Description:

Definitive Contact Lens

Treatment:

Device: Definitive Contact Lens

Cooper Vision Biofinity

Placebo Comparator group

Description:

Biofinity Contact Lens

Treatment:

Device: Biofinity