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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Air Optix Aqua
Biofinity
Proclear
Acuvue Oasys
Acuvue 2
Purevision
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Contact lenses, myopia, lens geometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Institute for Eye Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Air Optix Aqua

Biofinity

Proclear

Acuvue Oasys

Acuvue 2

Purevision

Arm Description

Contact lens material: Lotrafilcon A

Contact lens material: Comfilcon A

Contact lens material: Omafilcon A

Contact lens material: Senofilcon A

Contact lens material: Etafilcon A

Contact lens material: Balafilcon A

Outcomes

Primary Outcome Measures

Lens Geometry

Secondary Outcome Measures

Corneal Shape
Conjunctival Staining
The conjunctival staining

Full Information

First Posted
April 7, 2010
Last Updated
July 17, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01100411
Brief Title
Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses
Official Title
Changes in Invitro and ex Vivo Lens Metrology With Experienced Daily Wear Contact Lens Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate changes in contact lens geometry after lens wear
Detailed Description
The purpose of this study is to evaluate changes invitro and ex vivo in contact lens geometry in daily lens wear

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Contact lenses, myopia, lens geometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Air Optix Aqua
Arm Type
Active Comparator
Arm Description
Contact lens material: Lotrafilcon A
Arm Title
Biofinity
Arm Type
Active Comparator
Arm Description
Contact lens material: Comfilcon A
Arm Title
Proclear
Arm Type
Active Comparator
Arm Description
Contact lens material: Omafilcon A
Arm Title
Acuvue Oasys
Arm Type
Active Comparator
Arm Description
Contact lens material: Senofilcon A
Arm Title
Acuvue 2
Arm Type
Active Comparator
Arm Description
Contact lens material: Etafilcon A
Arm Title
Purevision
Arm Type
Active Comparator
Arm Description
Contact lens material: Balafilcon A
Intervention Type
Device
Intervention Name(s)
Air Optix Aqua
Other Intervention Name(s)
Air Optix
Intervention Description
Contact lens material: Lotrafilcon A
Intervention Type
Device
Intervention Name(s)
Biofinity
Other Intervention Name(s)
CV Biofininty
Intervention Description
Contact lens material: Comfilcon A
Intervention Type
Device
Intervention Name(s)
Proclear
Other Intervention Name(s)
Proclear Compatibles
Intervention Description
Contact lens material: Omafilcon A
Intervention Type
Device
Intervention Name(s)
Acuvue Oasys
Other Intervention Name(s)
Oasys
Intervention Description
Contact lens material: Senofilcon A
Intervention Type
Device
Intervention Name(s)
Acuvue 2
Other Intervention Name(s)
AV 2
Intervention Description
Contact lens material: Etafilcon A
Intervention Type
Device
Intervention Name(s)
Purevision
Other Intervention Name(s)
PV
Intervention Description
Contact lens material: Balafilcon A
Primary Outcome Measure Information:
Title
Lens Geometry
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Corneal Shape
Time Frame
1 week
Title
Conjunctival Staining
Description
The conjunctival staining
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Call Center
Organizational Affiliation
Alcon Research
Official's Role
Study Chair
Facility Information:
Facility Name
Institute for Eye Research
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2052
Country
Australia

12. IPD Sharing Statement

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

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