Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses

July 17, 2012 updated by: Alcon Research

Changes in Invitro and ex Vivo Lens Metrology With Experienced Daily Wear Contact Lens Wearers

The purpose of this study is to evaluate changes in contact lens geometry after lens wear

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate changes invitro and ex vivo in contact lens geometry in daily lens wear

Study Type

Interventional

Enrollment (Actual)

35

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

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2052
        • Institute for Eye Research

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;

    • Be at least 18 years old;
    • Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
    • Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
    • Has vision correctable to at least 6/12 (20/40) or better at distance in each eye with contact lenses;
    • Be experienced at wearing contact lenses.

Exclusion Criteria:

  • • Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;

    • Any systemic disease that adversely affects ocular health
    • An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
    • Use of any topical ocular medication during trial with the exception of saline drops ;
    • Use of or a need for any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance
    • Eye surgery within 12 weeks immediately prior to enrolment for this trial;
    • Previous corneal refractive surgery;
    • Contraindications to contact lens wear;
    • Participated or currently enrolled in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks;
    • Be pregnant (formal testing of pregnancy is not required. A participant's verbal report is sufficient);
    • Worn soft contact lenses 2 calendar days or rigid gas permeable/ orthokeratology lenses 7 calendar days prior.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Air Optix Aqua
Contact lens material: Lotrafilcon A
Device: Air Optix Aqua
Contact lens material: Lotrafilcon A
Other Names:
  • Air Optix
ACTIVE_COMPARATOR: Biofinity
Contact lens material: Comfilcon A
Device: Biofinity
Contact lens material: Comfilcon A
Other Names:
  • CV Biofininty
ACTIVE_COMPARATOR: Proclear
Contact lens material: Omafilcon A
Device: Proclear
Contact lens material: Omafilcon A
Other Names:
  • Proclear Compatibles
ACTIVE_COMPARATOR: Acuvue Oasys
Contact lens material: Senofilcon A
Device: Acuvue Oasys
Contact lens material: Senofilcon A
Other Names:
  • Oasys
ACTIVE_COMPARATOR: Acuvue 2
Contact lens material: Etafilcon A
Device: Acuvue 2
Contact lens material: Etafilcon A
Other Names:
  • AV 2
ACTIVE_COMPARATOR: Purevision
Contact lens material: Balafilcon A
Device: Purevision
Contact lens material: Balafilcon A
Other Names:
  • PV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lens Geometry
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal Shape
Time Frame: 1 week
1 week
Conjunctival Staining
Time Frame: 1 week
The conjunctival staining
1 week

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Chair: Alcon Call Center, Alcon Research

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

March 1, 2010

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

April 7, 2010

First Submitted That Met QC Criteria

April 7, 2010

First Posted (ESTIMATE)

April 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-10-01

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.

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