MyopiaNCT00725530

Evaluation of Deposits on Contact Lenses Worn Extended Wear

A study testing balafilcon A contact lens (PureVision) and etafilcon A contact lens (Acuvue2) in people with Myopia, run by Alcon Research at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: balafilcon A contact lens (PureVision) and etafilcon A contact lens (Acuvue2)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Oct 2008
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 or older.
Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
Successfully wearing hydrogel or silicone hydrogel contact lenses.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Evidence or history of ocular conditions as prescribed in the protocol.
One functional eye or a monofit lens.
Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol.
Use of concomitant topical ocular prescription or over-the-counter ocular medications.
History of seasonal allergies with significant ocular side effects.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.

Conditions: Myopia
Being tested: balafilcon A contact lens (PureVision), etafilcon A contact lens (Acuvue2)
Keywords: Lens deposits, Soft contact lens wearers
Medical subject headings: Myopia

What participants receive

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

balafilcon A contact lens (PureVision)Device
Also called PureVision
Commercially marketed, silicone hydrogel contact lens
etafilcon A contact lens (Acuvue2)Device
Also called Acuvue2
Commercially marketed, hydrogel contact lens

Study groups in NCT00725530
Study group	Role	What they receive
balafilcon A / etafilcon A	Active comparator	Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days. Receives: Device: balafilcon A contact lens (PureVision); Device: etafilcon A contact lens (Acuvue2)
etafilcon A / balafilcon A	Active comparator	Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days. Receives: Device: balafilcon A contact lens (PureVision); Device: etafilcon A contact lens (Acuvue2)

What is being measured

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

Front Surface Lens Deposits
Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).
Measured: 7 days

Timeline

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

Mar 2008Oct 2008

First posted30 Jul 2008 (estimated)
Study startMar 2008
Primary completionOct 2008
Study completionOct 2008

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.
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
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00725530
Sponsor's protocol ID: MS-007
Status last verified: Jul 2012
First submitted: 28 Jul 2008
Last updated: 22 Aug 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?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Deposits on Contact Lenses Worn Extended Wear
ClinicalTrials.gov ID: NCT00725530
Acronym / sponsor ID: MS-007
Conditions: Myopia
Keywords: Lens deposits, Soft contact lens wearers
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 30 Jul 2008 (estimated)
Results: Posted 22 Aug 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 study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
balafilcon A / etafilcon A	Active comparator	Device: balafilcon A contact lens (PureVision), Device: etafilcon A contact lens (Acuvue2)Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
etafilcon A / balafilcon A	Active comparator	Device: balafilcon A contact lens (PureVision), Device: etafilcon A contact lens (Acuvue2)Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 or older.
Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
Successfully wearing hydrogel or silicone hydrogel contact lenses.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (6 listed)

Evidence or history of ocular conditions as prescribed in the protocol.
One functional eye or a monofit lens.
Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol.
Use of concomitant topical ocular prescription or over-the-counter ocular medications.
History of seasonal allergies with significant ocular side effects.

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
balafilcon A contact lens (PureVision)Also: PureVisionCommercially marketed, silicone hydrogel contact lens	Device	balafilcon A / etafilcon A, etafilcon A / balafilcon A
etafilcon A contact lens (Acuvue2)Also: Acuvue2Commercially marketed, hydrogel contact lens	Device	balafilcon A / etafilcon A, etafilcon A / balafilcon A

Primary outcome

Front Surface Lens Deposits
Time frame: 7 days
Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).

Results and safety

Results posted to the registry on 22 Aug 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
Balafilcon A / Etafilcon A	27	27
Etafilcon A / Balafilcon A	27	27

Primary outcome: Front Surface Lens Deposits

Time frame: 7 days. Number. Unit: Participants

Measure	Balafilcon A n = 54	Etafilcon A n = 54
Deposits graded <2	20	25
Deposits graded >1	34	29

Population analysed: All enrolled participants.

Adverse events

Time frame: Adverse events were collected for the duration of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Balafilcon A Contact Lenses	0 of 54 (0%)	0 of 54 (0%)	Not reported
Etafilcon A	0 of 54 (0%)	0 of 54 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
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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
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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.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing balafilcon A contact lens (PureVision) and etafilcon A contact lens (Acuvue2) in people with Myopia, run by Alcon Research at 1 site in United States.

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 4 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 22 Aug 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 United States. 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?

Yes. Results are posted in the registry (first posted 22 Aug 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?

Front Surface Lens Deposits (time frame: 7 days). 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 NCT00725530.

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 22 Aug 2012.