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CompletedNCT01100411Updated Jul 18, 2012

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

An interventional study of Air Optix Aqua and Biofinity in Myopia, sponsored by Alcon Research. Completed at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-18.

Sponsored by Alcon Research · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Myopia

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Keywords

  • Contact lenses, myopia, lens geometry
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 209 are open to participants now.

This study's enrollment of 35 is below the median of 80 across 782 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Active comparator
    Air Optix Aqua

    Contact lens material: Lotrafilcon A

    Device: Air Optix Aqua

  • Active comparator
    Biofinity

    Contact lens material: Comfilcon A

    Device: Biofinity

  • Active comparator
    Proclear

    Contact lens material: Omafilcon A

    Device: Proclear

  • Active comparator
    Acuvue Oasys

    Contact lens material: Senofilcon A

    Device: Acuvue Oasys

  • Active comparator
    Acuvue 2

    Contact lens material: Etafilcon A

    Device: Acuvue 2

  • Active comparator
    Purevision

    Contact lens material: Balafilcon A

    Device: Purevision

Interventions

  • DeviceAir Optix Aqua

    Contact lens material: Lotrafilcon A

    Also known as: Air Optix

  • DeviceBiofinity

    Contact lens material: Comfilcon A

    Also known as: CV Biofininty

  • DeviceProclear

    Contact lens material: Omafilcon A

    Also known as: Proclear Compatibles

  • DeviceAcuvue Oasys

    Contact lens material: Senofilcon A

    Also known as: Oasys

  • DeviceAcuvue 2

    Contact lens material: Etafilcon A

    Also known as: AV 2

  • DevicePurevision

    Contact lens material: Balafilcon A

    Also known as: PV

06

What researchers measure

Primary outcomes

  1. Lens Geometry

    Time frame: 1 week

Secondary outcomes

  1. Corneal Shape

    Time frame: 1 week

  2. Conjunctival Staining

    The conjunctival staining

    Time frame: 1 week

07

Study locations

1 site
  • Institute for Eye Research
    Sydney, New South Wales 2052, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01100411
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Apr 9, 2010
Start date
Mar 2010
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Jul 18, 2012

Study contacts

Alcon Call Center
study chair · Alcon Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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