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

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).

Study Overview

• Status: Completed
• Conditions: Vision Correction
• Intervention / Treatment: Device: Definitive Contact Lens; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surry
    • Farnham, Surry, United Kingdom, GU9 7EN
      • Vision Care Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Contamac 74% silicone hydrogel contact lens; Definitive Contact Lens	Device: Definitive Contact Lens; Daily wear contact lens
Placebo Comparator: Cooper Vision Biofinity; Biofinity Contact Lens	Device: Biofinity; Daily wear contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy.	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.	3 months

Collaborators and Investigators

• Sponsor: Contamac Ltd
• Investigators: Principal Investigator: Graeme Young, Vision Care Research

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: September 8, 2010
• First Posted (Estimate): September 9, 2010

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CCSH-1901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No