MyopiaPhase 4NCT00640341

Comparative Performance of PureVision, Acuvue Oasys and O2Optix

A Phase 4 study testing PureVision Contact Lens, Acuvue Oasys Contact Lens and O2Optix Contact lens in people with Myopia, run by Bausch & Lomb Incorporated 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 objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: PureVision Contact Lens, Acuvue Oasys Contact Lens and O2Optix Contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 510 participants
Where: 1 siteUnited States
Study dates: Feb 2008to Apr 2008
Phase: Phase 4
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

Subject is myopic
VA correctable to 0.3 LogMAR or better (driving vision)
Clear central cornea
Subject uses a lens care system on a regular basis

Who cannot join

Systemic disease affecting ocular health
Using systemic or topical medications
Wear monovision, multifocal or toric contact lenses
Any grade 2 or greater slit lamp findings

Trial locations and contacts

1 site in 1 country.

United States1 site

Anderson & Associates
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Product Performance of Bausch & Lomb PureVision® Contact Lens When Compared to Johnson & Johnson Acuvue Oasys Contact Lens and the Ciba Vision O2Optix Contact Lens Worn Daily.

The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis.

Conditions: Myopia
Being tested: PureVision Contact Lens, Acuvue Oasys Contact Lens, O2Optix 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.

PureVision Contact LensDevice
contact lens for daily wear
Acuvue Oasys Contact LensDevice
contact lens for daily wear
O2Optix Contact lensDevice
contact lens for daily wear

Study groups in NCT00640341
Study group	Role	What they receive
PureVision	Experimental	PureVision Contact Lens Receives: Device: PureVision Contact Lens
Acuvue Oasys	Active comparator	Acuvue Oasys Contact Lens Receives: Device: Acuvue Oasys Contact Lens
O2Optix	Active comparator	O2Optix Contact Lens Receives: Device: O2Optix Contact lens

What is being measured

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

Any Slit Lamp Finding > Grade 2
All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal \& bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.
Measured: Over all follow-up visits for the 1 month study period
Subjective Responses to Comfort-related Symptoms/Complaints
Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.
Measured: Over all follow-up visits for 1 month study period
Uncorrected Distance High Contrast Visual Acuity
logMAR high contrast visual acuity (VA) over all visits.
Measured: Over all visits for the 1 month study period

Timeline

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

Feb 2008Apr 2008

First posted21 Mar 2008 (estimated)
Study startFeb 2008
Primary completionApr 2008
Study completionApr 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.
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 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 510 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00640341
Sponsor's protocol ID: 552
Status last verified: Dec 2011
First submitted: 20 Feb 2008
Last updated: 12 Dec 2011
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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Product Performance of Bausch & Lomb PureVision® Contact Lens When Compared to Johnson & Johnson Acuvue Oasys Contact Lens and the Ciba Vision O2Optix Contact Lens Worn Daily.
ClinicalTrials.gov ID: NCT00640341
Acronym / sponsor ID: 552
Conditions: Myopia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 510 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 21 Mar 2008 (estimated)
Results: Posted 31 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
PureVision	Experimental	Device: PureVision Contact LensPureVision Contact Lens
Acuvue Oasys	Active comparator	Device: Acuvue Oasys Contact LensAcuvue Oasys Contact Lens
O2Optix	Active comparator	Device: O2Optix Contact lensO2Optix Contact Lens

Who may qualify

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

Key inclusion criteria (4 listed)

Subject is myopic
VA correctable to 0.3 LogMAR or better (driving vision)
Clear central cornea
Subject uses a lens care system on a regular basis

Key exclusion criteria (4 listed)

Systemic disease affecting ocular health
Using systemic or topical medications
Wear monovision, multifocal or toric contact lenses
Any grade 2 or greater slit lamp findings

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
PureVision Contact Lenscontact lens for daily wear	Device	PureVision
Acuvue Oasys Contact Lenscontact lens for daily wear	Device	Acuvue Oasys
O2Optix Contact lenscontact lens for daily wear	Device	O2Optix

Primary outcome

Any Slit Lamp Finding > Grade 2
Time frame: Over all follow-up visits for the 1 month study period
All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal \& bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.
Subjective Responses to Comfort-related Symptoms/Complaints
Time frame: Over all follow-up visits for 1 month study period
Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.
Uncorrected Distance High Contrast Visual Acuity
Time frame: Over all visits for the 1 month study period
logMAR high contrast visual acuity (VA) over all visits.

Results and safety

Results posted to the registry on 31 Mar 2011, 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	170	149
Acuvue Oasys	170	165
O2Optix	170	163

Primary outcome: Any Slit Lamp Finding > Grade 2

Time frame: Over all follow-up visits for the 1 month study period. Number. Unit: Eyes

Measure	PureVision n = 162	Acuvue Oasys n = 169	O2Optix n = 168
Value	2	5	10

Population analysed: All dispensed eyes

Primary outcome: Subjective Responses to Comfort-related Symptoms/Complaints

Time frame: Over all follow-up visits for 1 month study period. Mean (Standard Deviation). Unit: Units on a Scale

Measure	PureVision n = 157	Acuvue Oasys n = 167	O2Optix n = 164
Morning Comfort	85.5 (17.55)	92.9 (11.97)	92.0 (12.79)
Comfort Throughout the Day	82.9 (18.94)	90.1 (14.47)	88.4 (13.43)
End of Day Comfort	76.1 (21.86)	85.2 (16.69)	81.4 (18.40)
Lens Awareness	79.9 (23.46)	89.5 (16.30)	86.4 (17.91)
Irritation	81.7 (20.15)	90.5 (14.42)	87.0 (15.89)
Itching	89.9 (15.75)	93.5 (12.81)	92.2 (13.57)
Dryness	81.9 (20.22)	89.1 (14.42)	85.0 (17.46)
Redness	91.0 (14.93)	94.5 (11.14)	91.9 (14.23)

Population analysed: All eligible dispensed eyes.

Primary outcome: Uncorrected Distance High Contrast Visual Acuity

Time frame: Over all visits for the 1 month study period. Mean (Standard Deviation). Unit: LogMAR

Measure	PureVision n = 164	Acuvue Oasys n = 167	O2Optix n = 168
Value	-0.031 (0.070)	-0.026 (0.071)	-0.024 (0.0760)

Population analysed: All eligible dispensed eyes.

Adverse events

Time frame: 1 month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PureVision	0 of 340 (0%)	0 of 340 (0%)	Not reported
Acuvue Oasys	0 of 340 (0%)	0 of 340 (0%)	Not reported
O2Optix	0 of 340 (0%)	0 of 340 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
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.

Gerard Cairns, MCOptom, PhD study director

Bausch & Lomb Incorporated

Bruce Anderson, OD principal investigator

Anderson & Associates

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PureVision Contact Lens, Acuvue Oasys Contact Lens and O2Optix Contact lens in people with Myopia, run by Bausch & Lomb Incorporated 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 4 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 12 Dec 2011. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2011). 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?

Any Slit Lamp Finding > Grade 2 (time frame: Over all follow-up visits for the 1 month study period). The study lists 3 primary outcomes in all. 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 NCT00640341.

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 12 Dec 2011.