Skip to main content
OpenTrials
Completed

NCT Number: NCT00940459

Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contact Lenses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Optometric Technology Group Ltd

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Minimum age of 18 years old
  • Adapted contact lens wearer
  • Sign informed consent
  • Normal eyes with the exception of the need for visual correction
  • Astigmatism less than or equal to -0.75 diopter
  • Spherical prescription range between -10.00 and +6.00 diopters
  • Other protocol-defined inclusion criteria may apply

Exclusion criteria

  • Any known sensitivity to the test articles used in the study
  • Monocular vision
  • Lid or conjunctival infections or abnormalities
  • Conjunctival staining greater than Grade 1
  • Corneal staining greater than Grade 2
  • Corneal edema or opacifications
  • Aphakia
  • Any previous corneal surgery
  • Iritis
  • Recent significant changes in visual acuity
  • Ocular disease that contraindicates contact lens wear
  • Tarsal abnormalities greater than Grade 2
  • Any ophthalmic medication
  • Any systemic medication or condition that might affect the subject's participation in the study
  • Chronic upper respiratory infections or colds
  • Pregnancy or planning to become pregnant
  • Lactation
  • Seasonal allergies
  • Known infections or immunosuppressive disease
  • Participation in other studies
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Senofilcon A contact lens (ACUVUE OASYS)

Device

Silicone hydrogel contact lens CE-marked for the intended usage.

Other names: ACUVUE® OASYS™

Comfilcon A contact lens (Biofinity)

Device

Silicone hydrogel contact lens CE-marked for the intended usage.

Other names: Biofinity®

Lotrafilcon B contact lens (Air Optix)

Device

Silicone hydrogel contact lens CE-marked for the intended usage.

Other names: Air Optix®

balafilcon A contact lens (PureVision)

Device

Silicone hydrogel contact lens CE-marked for the intended usage.

Other names: PureVision®

Etafilcon A contact lens (Acuvue 2)

Device

Hydrogel contact lens CE-marked for the intended usage.

Other names: ACUVUE® 2

Contact lens care system (EasySept)

Device

Contact lens care system CE-marked for the intended usage.

Other names: EasySept

Primary outcomes

  1. Circumlimbal Conjunctival Staining (CCS)

    Time frame: After 10 days of wear

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 16, 2009
Registry last updated
Nov 16, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.