MyopiaNCT01185834

Assessment of Lotrafilcon A Contact Lenses

A study testing Lotrafilcon A upgrade soft 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 3-month study is to evaluate subjective responses to an upgraded contact lens. Read more about this study

Who is it for?: Any age
Conditions the study is for: Myopia
What is being tested?: Lotrafilcon A upgrade soft contact lens
Type of treatment: Medical device
How many people: 118 participants
Where: No sites listed yet
Study dates: Jul 2010to Dec 2010
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

Have normal ocular findings.
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.
Wear Night \& Day contact lenses.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Require concurrent ocular medication.
Eye injury or surgery within twelve weeks prior to enrollment.
Currently enrolled in an ophthalmic clinical trial.
Any active corneal infection.
Corneal refractive surgery.
Wear AIR OPTIX NIGHT \& DAY AQUA lenses.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.

Conditions: Myopia
Being tested: Lotrafilcon A upgrade soft 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 upgrade soft contact lensDevice
Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.

What is being measured

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

Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 3 months of wear, replacing lenses monthly

Secondary outcomes (1)

Overall Lens Fit
As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight
Measured: 3 months of wear, replacing lenses monthly

Timeline

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

Jul 2010Dec 2010

First posted20 Aug 2010 (estimated)
Study startJul 2010
Primary completionDec 2010
Study completionDec 2010

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: Single blind
Who is masked: Participant
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01185834
Sponsor's protocol ID: P-335-C-015
Status last verified: Dec 2011
First submitted: 18 Aug 2010
Last updated: 10 Jul 2012
Results posted: Yes, on ClinicalTrials.gov

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

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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: Assessment of Lotrafilcon A Contact Lenses
ClinicalTrials.gov ID: NCT01185834
Acronym / sponsor ID: P-335-C-015
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 20 Aug 2010 (estimated)
Results: Posted 24 Jan 2012

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 3-month study is to evaluate subjective responses to an upgraded contact lens.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (participant)

Who may qualify

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

Key inclusion criteria (5 listed)

Have normal ocular findings.
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.
Wear Night \& Day contact lenses.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (7 listed)

Require concurrent ocular medication.
Eye injury or surgery within twelve weeks prior to enrollment.
Currently enrolled in an ophthalmic clinical trial.
Any active corneal infection.
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 upgrade soft contact lensSilicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.	Device	–

Primary outcome

Overall Comfort
Time frame: 3 months of wear, replacing lenses monthly
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

1 secondary outcome

Overall Lens Fit
Time frame: 3 months of wear, replacing lenses monthly

Results and safety

Results posted to the registry on 24 Jan 2012, 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	118	104

Primary outcome: Overall Comfort

Time frame: 3 months of wear, replacing lenses monthly. Mean (Standard Deviation). Unit: units on a scale

Measure	Lotrafilcon A n = 103
Value	8.4 (1.6)

Population analysed: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected for the duration of the trial: 143 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lotrafilcon A	0 of 118 (0%)	0 of 118 (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 upgrade soft 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 7 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 24 Jan 2012). 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?

Overall Comfort (time frame: 3 months of wear, replacing lenses monthly). 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 NCT01185834.

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.