Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

November 15, 2016 updated by: Alcon Research
The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Optometric Technology Group Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acuvue Oasys
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Device: Senofilcon A contact lens (Acuvue Oasys)
Silicone hydrogel contact lens CE-marked for the intended usage.
Other Names:
  • ACUVUE® OASYS™
Device: Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Names:
  • EasySept
Experimental: Biofinity
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Device: Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Names:
  • EasySept
Device: Comfilcon A contact lens (Biofinity)
Silicone hydrogel contact lens CE-marked for the intended usage.
Other Names:
  • Biofinity®
Experimental: Air Optix
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Device: Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Names:
  • EasySept
Device: Lotrafilcon B contact lens (Air Optix)
Silicone hydrogel contact lens CE-marked for the intended usage.
Other Names:
  • Air Optix®
Experimental: PureVision
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Device: Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Names:
  • EasySept
Device: Balafilcon A contact lens (PureVision)
Silicone hydrogel contact lens CE-marked for the intended usage.
Other Names:
  • PureVision®
Active Comparator: Acuvue 2
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Device: Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Names:
  • EasySept
Device: Etafilcon A contact lens (Acuvue 2)
Hydrogel contact lens CE-marked for the intended usage.
Other Names:
  • ACUVUE® 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Circumlimbal Conjunctival Staining (CCS)
Time Frame: After 10 days of wear
After 10 days of wear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 16, 2009

Study Record Updates

Last Update Posted (Estimate)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M-09-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contact Lenses

Clinical Trials on Senofilcon A contact lens (Acuvue Oasys)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe