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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01100411
First received: April 7, 2010
Last updated: July 17, 2012
Last verified: November 2011
  Purpose

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


Condition Intervention
Myopia
Device: Air Optix Aqua
Device: Biofinity
Device: Proclear
Device: Acuvue Oasys
Device: Acuvue 2
Device: Purevision

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Changes in Invitro and ex Vivo Lens Metrology With Experienced Daily Wear Contact Lens Wearers

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Lens Geometry [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Corneal Shape [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Conjunctival Staining [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    The conjunctival staining


Enrollment: 35
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Air Optix Aqua
Contact lens material: Lotrafilcon A
Device: Air Optix Aqua
Contact lens material: Lotrafilcon A
Other Name: Air Optix
Active Comparator: Biofinity
Contact lens material: Comfilcon A
Device: Biofinity
Contact lens material: Comfilcon A
Other Name: CV Biofininty
Active Comparator: Proclear
Contact lens material: Omafilcon A
Device: Proclear
Contact lens material: Omafilcon A
Other Name: Proclear Compatibles
Active Comparator: Acuvue Oasys
Contact lens material: Senofilcon A
Device: Acuvue Oasys
Contact lens material: Senofilcon A
Other Name: Oasys
Active Comparator: Acuvue 2
Contact lens material: Etafilcon A
Device: Acuvue 2
Contact lens material: Etafilcon A
Other Name: AV 2
Active Comparator: Purevision
Contact lens material: Balafilcon A
Device: Purevision
Contact lens material: Balafilcon A
Other Name: PV

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100411

Locations
Australia, New South Wales
Institute for Eye Research
Sydney, New South Wales, Australia, 2052
Sponsors and Collaborators
Alcon Research
Investigators
Study Chair: Alcon Call Center Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01100411     History of Changes
Other Study ID Numbers: M-10-01
Study First Received: April 7, 2010
Last Updated: July 17, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Keywords provided by Alcon Research:
Contact lenses, myopia, lens geometry

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014