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OpenTrials
Completed

NCT Number: NCT01197859

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).

Completed

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Key information

Conditions

Vision Correction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vision Care Research

Farnham, Surry, GU9 7EN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Definitive Contact Lens

Device

Daily wear contact lens

Biofinity

Device

Daily wear contact lens

Primary outcomes

  1. Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Contamac Ltd

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 9, 2010
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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