MyopiaNCT00813761

Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems

A study testing O2Optix contact lens, Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 26 sites in 2 countries.

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 is to compare two marketed contact lens care solutions in regards to comfort and ocular health. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: O2Optix contact lens, Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 473 participants
Where: 26 sitesin 2 countries
Study dates: 1 Sep 2008to 1 Aug 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be at least 18 years old.
Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
Require a visual correction in both eyes (monovision allowed but not monofit).
Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
Have normal eyes with no evidence of abnormality or disease.

Who cannot join

Requires concurrent ocular medication.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
Worn lenses on an extended wear basis in the last 3 months.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

Show all 9Show fewer

Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
Abnormal lacrimal secretions.

Trial locations and contacts

26 sites in 2 countries.

Country

City, postcode or hospital

26 sites in 2 countries

United States25 sites

Study site
Bartlett, Tennessee
Study site
Bloomington, Illinois
Study site
Burlington, Vermont
Study site
Campbell, California
Study site
Chagrin Falls, Ohio
Study site
Chamberlain, South Dakota
Study site
Colorado Springs, Colorado
Study site
Cupertino, California
Study site
Florence, New Jersey
Study site
Kittanning, Pennsylvania
Study site
Laguna Niguel, California
Study site
Midlothian, Virginia
Study site
Mission Viejo, California
Study site
Moon Township, Pennsylvania
Study site
Nanticoke, Pennsylvania
Study site
Neodesha, Kansas
Study site
North Little Rock, Arkansas
Study site
Raytown, Missouri
Study site
Salt Lake City, Utah
Study site
San Clemente, California
Study site
State College, Pennsylvania
Study site
Virginia Beach, Virginia
Study site
Warren, Ohio
Study site
Warrensburg, Missouri
Study site
Warwick, Rhode Island

Other trials in United States

United Kingdom1 site

Study site
Aston Triangle, Birmingham

Other trials in United Kingdom

About this study

The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.

Conditions: Myopia
Being tested: O2Optix contact lens, Proclear contact lens, ReNu MultiPlus Multi-Purpose Solution, Clear Care Cleaning and Disinfecting Solution
Medical subject headings: Myopia

What participants receive

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

O2Optix contact lensDevice
control contact lens to be worn daily for approximately 7 months for entire length of study.
Proclear contact lensDevice
control contact lens to be worn for entire length of study.
ReNu MultiPlus Multi-Purpose SolutionDevice
lens solution for overnight lens disinfection
Clear Care Cleaning and Disinfecting SolutionDevice
lens solution for overnight lens disinfection

Study groups in NCT00813761
Study group	Role	What they receive
02Optix CL and ReNu MPS with SICS	Other	O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution Receives: Device: O2Optix contact lens; Device: ReNu MultiPlus Multi-Purpose Solution
Proclear CL and ReNu MPS with SICS	Other	Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution Receives: Device: Proclear contact lens; Device: ReNu MultiPlus Multi-Purpose Solution
02Optix CL and Clear Care LCS with SICS	Other	O2Optix contact lens and Clear Care lens care solution subject Receives: Device: O2Optix contact lens; Device: Clear Care Cleaning and Disinfecting Solution
Proclear CL and Clear Care LCS with SICS	Other	Proclear contact lens and Clear Care lens care solution Receives: Device: Proclear contact lens; Device: Clear Care Cleaning and Disinfecting Solution
02Optix CL and ReNu MPS without SICS	Other	O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution Receives: Device: O2Optix contact lens; Device: ReNu MultiPlus Multi-Purpose Solution
Proclear CL and ReNu MPS without SICS	Other	Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution Receives: Device: Proclear contact lens; Device: ReNu MultiPlus Multi-Purpose Solution
02Optix CL and Clear Care LCS without SICS	Other	O2Optix contact lens and Clear Care lens care solution Receives: Device: O2Optix contact lens; Device: Clear Care Cleaning and Disinfecting Solution
Proclear CL and Clear Care LCS without SICS	Other	Proclear contact lens and Clear Care lens care solution Receives: Device: Proclear contact lens; Device: Clear Care Cleaning and Disinfecting Solution

What is being measured

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

Average Daily Wear Time
Average hours per day that contact lens were worn.
Measured: 24 weeks
Average Daily Comfortable Wear Time
Average hours per day that contact lens were worn comfortably.
Measured: 24 weeks
Lens Comfort
Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.
Measured: 24 weeks
Frequency of Eye Discomfort
Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Measured: 24 weeks
Frequency of Daily Lens Dryness
Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Measured: 24 weeks
Frequency of Eye Burning/Stinging
Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Measured: 24 weeks
Frequency of Itching
Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Measured: 24 weeks
Frequency of Tearing
Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Measured: 24 weeks
Average Corneal Fluorescein Type Staining
staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.
Measured: 24 weeks
Average Corneal Fluorescein Staining Area
corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.
Measured: 24 weeks
Limbal Redness
Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Measured: 24 weeks
Bulbar Redness
Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Measured: 24 weeks
Lower Tarsal Redness
Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Measured: 24 weeks
Upper Tarsal Redness
Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Measured: 24 weeks
Tarsal Roughness
The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency \& superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae
Measured: 24 weeks

Secondary outcomes (3)

Intensity of Physiological Outcomes
Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to "Solution Induced Corneal Staining (SICS)". These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5.
Measured: 24 weeks
Wearing Time and Comfortable Wearing Time
Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Average wearing time and average comfortable wearing time.
Measured: 24 weeks
Physiological Responses
Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale).
Measured: 24 weeks

Timeline

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

1 Sep 20081 Aug 2009

First posted23 Dec 2008 (estimated)
Study start1 Sep 2008
Primary completion1 Aug 2009
Study completion1 Aug 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 473 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00813761
Sponsor's protocol ID: CR-4522
Status last verified: Jun 2017
First submitted: 17 Dec 2008
Last updated: 19 Jun 2018
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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Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
ClinicalTrials.gov ID: NCT00813761
Acronym / sponsor ID: CR-4522
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 473 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Sep 2008 (actual)
Primary completion: 1 Aug 2009 (actual)
Study completion: 1 Aug 2009 (actual)
First posted: 23 Dec 2008 (estimated)
Results: Posted 24 Nov 2011

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 is to compare two marketed contact lens care solutions in regards to comfort and ocular health.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
02Optix CL and ReNu MPS with SICS	Other	Device: O2Optix contact lens, Device: ReNu MultiPlus Multi-Purpose SolutionO2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
Proclear CL and ReNu MPS with SICS	Other	Device: Proclear contact lens, Device: ReNu MultiPlus Multi-Purpose SolutionProclear contact lens and ReNu MultiPlus Multi-Purpose Solution
02Optix CL and Clear Care LCS with SICS	Other	Device: O2Optix contact lens, Device: Clear Care Cleaning and Disinfecting SolutionO2Optix contact lens and Clear Care lens care solution subject
Proclear CL and Clear Care LCS with SICS	Other	Device: Proclear contact lens, Device: Clear Care Cleaning and Disinfecting SolutionProclear contact lens and Clear Care lens care solution
02Optix CL and ReNu MPS without SICS	Other	Device: O2Optix contact lens, Device: ReNu MultiPlus Multi-Purpose SolutionO2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
Proclear CL and ReNu MPS without SICS	Other	Device: Proclear contact lens, Device: ReNu MultiPlus Multi-Purpose SolutionProclear contact lens and ReNu MultiPlus Multi-Purpose Solution
02Optix CL and Clear Care LCS without SICS	Other	Device: O2Optix contact lens, Device: Clear Care Cleaning and Disinfecting SolutionO2Optix contact lens and Clear Care lens care solution
Proclear CL and Clear Care LCS without SICS	Other	Device: Proclear contact lens, Device: Clear Care Cleaning and Disinfecting SolutionProclear contact lens and Clear Care lens care solution

Who may qualify

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

Key inclusion criteria (7 listed)

Be at least 18 years old.
Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
Require a visual correction in both eyes (monovision allowed but not monofit).
Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.

Key exclusion criteria (9 listed)

Requires concurrent ocular medication.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
Worn lenses on an extended wear basis in the last 3 months.
Diabetic.

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
O2Optix contact lenscontrol contact lens to be worn daily for approximately 7 months for entire length of study.	Device	02Optix CL and Clear Care LCS with SICS, 02Optix CL and Clear Care LCS without SICS, 02Optix CL and ReNu MPS with SICS, 02Optix CL and ReNu MPS without SICS
Proclear contact lenscontrol contact lens to be worn for entire length of study.	Device	Proclear CL and Clear Care LCS with SICS, Proclear CL and Clear Care LCS without SICS, Proclear CL and ReNu MPS with SICS, Proclear CL and ReNu MPS without SICS
ReNu MultiPlus Multi-Purpose Solutionlens solution for overnight lens disinfection	Device	02Optix CL and ReNu MPS with SICS, 02Optix CL and ReNu MPS without SICS, Proclear CL and ReNu MPS with SICS, Proclear CL and ReNu MPS without SICS
Clear Care Cleaning and Disinfecting Solutionlens solution for overnight lens disinfection	Device	02Optix CL and Clear Care LCS with SICS, 02Optix CL and Clear Care LCS without SICS, Proclear CL and Clear Care LCS with SICS, Proclear CL and Clear Care LCS without SICS

Primary outcome

Average Daily Wear Time
Time frame: 24 weeks
Average hours per day that contact lens were worn.
Average Daily Comfortable Wear Time
Time frame: 24 weeks
Average hours per day that contact lens were worn comfortably.
Lens Comfort
Time frame: 24 weeks
Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.
Frequency of Eye Discomfort
Time frame: 24 weeks
Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Frequency of Daily Lens Dryness
Time frame: 24 weeks
Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Frequency of Eye Burning/Stinging
Time frame: 24 weeks
Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Frequency of Itching
Time frame: 24 weeks
Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Frequency of Tearing
Time frame: 24 weeks
Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Average Corneal Fluorescein Type Staining
Time frame: 24 weeks
staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.
Average Corneal Fluorescein Staining Area
Time frame: 24 weeks
corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.
Limbal Redness
Time frame: 24 weeks
Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Bulbar Redness
Time frame: 24 weeks
Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Lower Tarsal Redness
Time frame: 24 weeks
Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Upper Tarsal Redness
Time frame: 24 weeks
Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Tarsal Roughness
Time frame: 24 weeks
The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency \& superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae

3 secondary outcomes

Intensity of Physiological Outcomes
Time frame: 24 weeks
Wearing Time and Comfortable Wearing Time
Time frame: 24 weeks
Physiological Responses
Time frame: 24 weeks

Results and safety

Results posted to the registry on 24 Nov 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
02Optix CL and ReNu MPS	121	117
Proclear CL and ReNu MPS	103	100
02Optix CL and Clear Care LCS	115	103
Proclear CL and Clear Care LCS	107	105

Primary outcome: Average Daily Wear Time

Time frame: 24 weeks. Least squares mean (Standard Error). Unit: Hours

Measure	Clear Care Lens Cleaning Solution (LCS) n = 194	ReNU Multi Purpose Solution (MPS) n = 192
Value	13.57 (0.23)	13.30 (0.23)

Population analysed: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Primary outcome: Average Daily Comfortable Wear Time

Time frame: 24 weeks. Least squares mean (Standard Error). Unit: Hours

Measure	Clear Care LCS n = 194	ReNU MPS n = 192
Value	11.96 (0.29)	11.39 (0.29)

Population analysed: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Primary outcome: Lens Comfort

Time frame: 24 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Clear Care LCS n = 194	ReNU MPS n = 192
Value	8.63 (0.13)	8.25 (0.13)

Population analysed: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

Primary outcome: Frequency of Eye Discomfort

Time frame: 24 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Clear Care LCS n = 194	ReNU MPS n = 192
Value	0.36 (0.05)	0.46 (0.05)

Population analysed: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
02Optix CL and ReNu MPS	0 of 121 (0%)	0 of 121 (0%)	Not reported
Proclear CL and ReNu MPS	0 of 103 (0%)	0 of 103 (0%)	Not reported
02Optix CL and Clear Care LCS	0 of 115 (0%)	0 of 115 (0%)	Not reported
Proclear CL and Clear Care LCS	1 of 107 (0.9%)	0 of 107 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

26 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing O2Optix contact lens, Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 26 sites in 2 countries.

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 7 inclusion and 9 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, United Kingdom. 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 24 Nov 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?

Average Daily Wear Time (time frame: 24 weeks). The study lists 15 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 NCT00813761.

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 19 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.