MyopiaNCT01100411
Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses
A study testing Air Optix Aqua, Biofinity and Proclear in people with Myopia, run by Alcon Research at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate changes in contact lens geometry after lens wear Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Air Optix Aqua, Biofinity and Proclear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2010to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Myopia
- Being tested
- Air Optix Aqua, Biofinity, Proclear, Acuvue Oasys, Acuvue 2
- Keywords
- Contact lenses, myopia, lens geometry
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Optix AquaDevice
Also called Air Optix
Contact lens material: Lotrafilcon A
BiofinityDevice
Also called CV Biofininty
Contact lens material: Comfilcon A
ProclearDevice
Also called Proclear Compatibles
Contact lens material: Omafilcon A
Acuvue OasysDevice
Also called Oasys
Contact lens material: Senofilcon A
Acuvue 2Device
Also called AV 2
Contact lens material: Etafilcon A
PurevisionDevice
Also called PV
Contact lens material: Balafilcon A
| Study group | Role | What they receive |
|---|---|---|
| Air Optix Aqua | Active comparator | Contact lens material: Lotrafilcon A Receives: Device: Air Optix Aqua |
| Biofinity | Active comparator | Contact lens material: Comfilcon A Receives: Device: Biofinity |
| Proclear | Active comparator | Contact lens material: Omafilcon A Receives: Device: Proclear |
| Acuvue Oasys | Active comparator | Contact lens material: Senofilcon A Receives: Device: Acuvue Oasys |
| Acuvue 2 | Active comparator | Contact lens material: Etafilcon A Receives: Device: Acuvue 2 |
| Purevision | Active comparator | Contact lens material: Balafilcon A Receives: Device: Purevision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Geometry
Measured: 1 week
Secondary outcomes (2)
Corneal Shape
Measured: 1 week
Conjunctival Staining
The conjunctival staining
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon Call Center, Study chair, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100411
- Sponsor's protocol ID
- M-10-01
- Status last verified
- Nov 2011
- First submitted
- 7 Apr 2010
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Invitro and ex Vivo Lens Metrology With Experienced Daily Wear Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT01100411
- Acronym / sponsor ID
- M-10-01
- Conditions
- Myopia
- Keywords
- Contact lenses, myopia, lens geometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Air Optix Aqua | Active comparator | Device: Air Optix AquaContact lens material: Lotrafilcon A |
| Biofinity | Active comparator | Device: BiofinityContact lens material: Comfilcon A |
| Proclear | Active comparator | Device: ProclearContact lens material: Omafilcon A |
| Acuvue Oasys | Active comparator | Device: Acuvue OasysContact lens material: Senofilcon A |
| Acuvue 2 | Active comparator | Device: Acuvue 2Contact lens material: Etafilcon A |
| Purevision | Active comparator | Device: PurevisionContact lens material: Balafilcon A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
Key exclusion criteria (11 listed)
- • 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air Optix AquaAlso: Air OptixContact lens material: Lotrafilcon A | Device | Air Optix Aqua |
| BiofinityAlso: CV BiofinintyContact lens material: Comfilcon A | Device | Biofinity |
| ProclearAlso: Proclear CompatiblesContact lens material: Omafilcon A | Device | Proclear |
| Acuvue OasysAlso: OasysContact lens material: Senofilcon A | Device | Acuvue Oasys |
| Acuvue 2Also: AV 2Contact lens material: Etafilcon A | Device | Acuvue 2 |
| PurevisionAlso: PVContact lens material: Balafilcon A | Device | Purevision |
Primary outcome
Lens Geometry
Time frame: 1 week
2 secondary outcomes
Corneal Shape
Time frame: 1 week
Conjunctival Staining
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alcon Call Center study chair
Alcon Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Optix Aqua, Biofinity and Proclear in people with Myopia, run by Alcon Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lens Geometry (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.