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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014