Refractive ErrorNCT00725153

Evaluation of Deposits on Contact Lenses Worn Daily Wear

A study testing Balafilcon A contact lenses (PureVision) and Etafilcon A contact lenses (Acuvue2) in people with Refractive Error, 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 front surface deposits on contact lenses when worn for ten hours. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error
What is being tested?: Balafilcon A contact lenses (PureVision) and Etafilcon A contact lenses (Acuvue2)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Sep 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

18 years 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 prior to enrollment in the study.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Evidence or history of keratitis (dendritic keratitis); viral disease of the cornea and/or conjunctiva; acute bacterial disease of the cornea and/or conjunctiva and/or eyelids; infection of the eye; and/or fungal disease of the eye.
One functional eye or a monofit lens.
Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis.
Any slit-lamp finding score of (1) at the Screening Visit as defined in protocol.
Use of concomitant topical ocular prescription or over-the-counter (OTC) ocular medications.
History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear.
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 front surface deposits on contact lenses when worn for ten hours.

Conditions: Refractive Error
Being tested: Balafilcon A contact lenses (PureVision), Etafilcon A contact lenses (Acuvue2)
Keywords: Contact lens deposits, Soft contact lenses, Myopia
Medical subject headings: Refractive Errors, Myopia

What participants receive

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

Balafilcon A contact lenses (PureVision)Device
Also called PureVision
Commercially marketed, soft contact lenses worn bilaterally for 10 hours
Etafilcon A contact lenses (Acuvue2)Device
Also called Acuvue2
Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Study groups in NCT00725153
Study group	Role	What they receive
PureVision/Acuvue 2	Other	PureVision contact lenses worn first, with Acuvue 2 contact lenses worn second. Both products worn for 10 hours each. Receives: Device: Balafilcon A contact lenses (PureVision); Device: Etafilcon A contact lenses (Acuvue2)
Acuvue 2/PureVision	Other	Acuvue 2 contact lenses worn first, with PureVision contact lenses worn second. Both products worn for 10 hours each. Receives: Device: Balafilcon A contact lenses (PureVision); Device: Etafilcon A contact lenses (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 10 hours of 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: 10 hours

Timeline

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

Mar 2008Sep 2008

First posted30 Jul 2008 (estimated)
Study startMar 2008
Primary completionSep 2008
Study completionSep 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 Refractive ErrorStudies 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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00725153
Sponsor's protocol ID: MS-006
Status last verified: Jul 2012
First submitted: 28 Jul 2008
Last updated: 23 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 Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Deposits on Contact Lenses Worn Daily Wear
ClinicalTrials.gov ID: NCT00725153
Acronym / sponsor ID: MS-006
Conditions: Refractive Error
Keywords: Contact lens deposits, Soft contact lenses, Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 30 Jul 2008 (estimated)
Results: Posted 23 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 front surface deposits on contact lenses when worn for ten hours.

Study design

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

Arm	Type	Receives
PureVision/Acuvue 2	Other	Device: Balafilcon A contact lenses (PureVision), Device: Etafilcon A contact lenses (Acuvue2)PureVision contact lenses worn first, with Acuvue 2 contact lenses worn second. Both products worn for 10 hours each.
Acuvue 2/PureVision	Other	Device: Balafilcon A contact lenses (PureVision), Device: Etafilcon A contact lenses (Acuvue2)Acuvue 2 contact lenses worn first, with PureVision contact lenses worn second. Both products worn for 10 hours each.

Who may qualify

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

Key inclusion criteria (4 listed)

18 years 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 prior to enrollment in the study.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (7 listed)

Evidence or history of keratitis (dendritic keratitis); viral disease of the cornea and/or conjunctiva; acute bacterial disease of the cornea and/or conjunctiva and/or eyelids; infection of the eye; and/or fungal disease of the eye.
One functional eye or a monofit lens.
Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis.
Any slit-lamp finding score of (1) at the Screening Visit as defined in protocol.
Use of concomitant topical ocular prescription or over-the-counter (OTC) ocular medications.

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 lenses (PureVision)Also: PureVisionCommercially marketed, soft contact lenses worn bilaterally for 10 hours	Device	Acuvue 2/PureVision, PureVision/Acuvue 2
Etafilcon A contact lenses (Acuvue2)Also: Acuvue2Commercially marketed, soft contact lenses worn bilaterally for 10 hours	Device	Acuvue 2/PureVision, PureVision/Acuvue 2

Primary outcome

Front Surface Lens Deposits
Time frame: 10 hours
Film and discrete deposits were assessed with a slit-lamp after 10 hours of 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 23 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
PureVision / Acuvue 2	27	27
Acuvue 2 / PureVision	28	28

Primary outcome: Front Surface Lens Deposits

Time frame: 10 hours. Number. Unit: Participants

Measure	PureVision Contact Lenses n = 55	Acuvue 2 Contact Lenses n = 55
Deposits Graded <2	27	32
Deposits Graded >1	28	23

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
PureVision Lenses Worn 10 Hours	0 of 55 (0%)	0 of 55 (0%)	Not reported
Acuvue 2 Lenses Worn 10 Hours	0 of 55 (0%)	0 of 55 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Clinical Performance and Outcomes After Toric Lens Transition
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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 lenses (PureVision) and Etafilcon A contact lenses (Acuvue2) in people with Refractive Error, 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 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 23 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 23 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: 10 hours). 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 NCT00725153.

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 23 Aug 2012.