MyopiaNCT00933166

Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

A study testing Lotrafilcon A contact lens in people with Myopia, run by CIBA VISION.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this trial is to assess the performance of an investigational contact lens over a three month period. Read more about this study

Who is it for?: Any age
Conditions the study is for: Myopia
What is being tested?: Lotrafilcon A contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 169 participants
Where: No sites listed yet
Study dates: Jun 2009to Nov 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
Be able to wear the study lenses in the available powers.
Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
Other protocol-defined inclusion/exclusion criteria may apply.

Who cannot join

Eye injury or surgery within twelve weeks of enrollment.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in an ophthalmic clinical trial.
Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
History of corneal refractive surgery.
Other protocol-defined inclusion/exclusion criteria may apply.

About this study

The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.

Conditions: Myopia
Being tested: Lotrafilcon A contact lens
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lotrafilcon A contact lensDevice
Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months

Study groups in NCT00933166
Study group	Role	What they receive
Lotrafilcon A	Experimental	Investigational contact lens worn in both eyes for three months Receives: Device: Lotrafilcon A contact lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Comfort After Insertion
Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Nov 2009

First posted7 Jul 2009 (estimated)
Study startJun 2009
Primary completionNov 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MyopiaStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00933166
Sponsor's protocol ID: P-335-C-014v2
Status last verified: Jan 2012
First submitted: 2 Jul 2009
Last updated: 10 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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Effect of IOP Lowering on Progressive HM
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
ClinicalTrials.gov ID: NCT00933166
Acronym / sponsor ID: P-335-C-014v2
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 7 Jul 2009 (estimated)
Results: Posted 23 Dec 2010

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 trial is to assess the performance of an investigational contact lens over a three month period.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lotrafilcon A	Experimental	Device: Lotrafilcon A contact lensInvestigational contact lens worn in both eyes for three months

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
Be able to wear the study lenses in the available powers.
Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
Other protocol-defined inclusion/exclusion criteria may apply.

Key exclusion criteria (6 listed)

Eye injury or surgery within twelve weeks of enrollment.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in an ophthalmic clinical trial.
Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
History of corneal refractive surgery.

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
Lotrafilcon A contact lensInvestigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months	Device	Lotrafilcon A

Primary outcome

Comfort After Insertion
Time frame: 3 months
Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Results and safety

Results posted to the registry on 23 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lotrafilcon A	169	151

Primary outcome: Comfort After Insertion

Time frame: 3 months. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Lotrafilcon A n = 122
Value	9.0 (1.6)

Population analysed: Analysis was per protocol and excluded ten major protocol deviations as determined by masked review. Eighteen participants discontinued prior to the Month 3 visit. Nineteen participants responded N/A due to reasons such as continual wear.

Adverse events

Time frame: Adverse event data were collected for the duration of the trial: 4 months, 16 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lotrafilcon A	0 of 169 (0%)	0 of 169 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Lotrafilcon A contact lens in people with Myopia, run by CIBA VISION.

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 5 inclusion and 6 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 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 23 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comfort After Insertion (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00933166.

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 10 Jul 2012.