MyopiaPhase 1/2NCT01024855

Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

A Phase 1/2 study of Myopia and Hyperopia, run by Abbott Medical Optics at 1 site in United States.

Completed

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

Trial summary

A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses. Read more about this study

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Myopia, Hyperopia, Astigmatism
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Apr 2009to Jun 2009
Phase: Phase 1/2
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 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

were at least 18 years old;
were experienced contact lens wearers;
were correctable to at least 20/40 or better in both eyes with contact lenses;
were in good general health, with healthy eyes (other than requiring vision correction);
had not worn lenses for at least 12 hours before each baseline visit;
had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
had previously used an MPS or hydrogen peroxide solution successfully.

Who cannot join

had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
were currently participating in any other clinical study;
had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Abbott Medical Optics Inc.
Santa Ana, California, 92705

Other trials in United States

About this study

A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Conditions: Myopia, Hyperopia, Astigmatism
Being tested: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
Medical subject headings: Myopia, Hyperopia, Astigmatism

What participants receive

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

RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)Device
multi-purpose lens care solution

Study groups in NCT01024855
Study group	Role	What they receive
RevitaLens OcuTec Multipurpose Solution (Investigational MPS)	Experimental	Not described Receives: Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
Opti-Free RepleniSH Multipurpose Solution (MPS, Control)	Active comparator	Not described Receives: Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)

What is being measured

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

Number of Eyes With No Change in Corneal Staining
Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.
Measured: Change from baseline after 1, 2, 4 and 6+ hours of wear

Timeline

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

Apr 2009Jun 2009

First posted3 Dec 2009 (estimated)
Study startApr 2009
Primary completionJun 2009
Study completionJun 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01024855
Sponsor's protocol ID: COBR-106-9608
Status last verified: Mar 2012
First submitted: 2 Dec 2009
Last updated: 20 Oct 2015
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?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
ClinicalTrials.gov ID: NCT01024855
Acronym / sponsor ID: COBR-106-9608
Conditions: Myopia, Hyperopia, Astigmatism
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Abbott Medical OpticsIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 3 Dec 2009 (estimated)
Results: Posted 29 Mar 2012

Clinical summary

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

A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
RevitaLens OcuTec Multipurpose Solution (Investigational MPS)	Experimental	Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
Opti-Free RepleniSH Multipurpose Solution (MPS, Control)	Active comparator	Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

were at least 18 years old;
were experienced contact lens wearers;
were correctable to at least 20/40 or better in both eyes with contact lenses;
were in good general health, with healthy eyes (other than requiring vision correction);
had not worn lenses for at least 12 hours before each baseline visit;

Key exclusion criteria (5 listed)

had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
were currently participating in any other clinical study;
had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

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
RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)multi-purpose lens care solution	Device	Opti-Free RepleniSH Multipurpose Solution (MPS, Control), RevitaLens OcuTec Multipurpose Solution (Investigational MPS)

Primary outcome

Number of Eyes With No Change in Corneal Staining
Time frame: Change from baseline after 1, 2, 4 and 6+ hours of wear
Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.

Results and safety

Results posted to the registry on 29 Mar 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
RevitaLens and OptiFree	30	29

Primary outcome: Number of Eyes With No Change in Corneal Staining

Time frame: Change from baseline after 1, 2, 4 and 6+ hours of wear. Number. Unit: eyes

Measure	RevitaLens n = 30	OptiFree n = 30
1 Hour - No Change	16	17
2 Hours - No Change	19	14
4 Hours - No Change	21	21
End of Day (>6 hrs) - No Change	19	20

Population analysed: per protocol

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RevitaLens and OptiFree	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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
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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study of Myopia and Hyperopia, run by Abbott Medical Optics 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 7 inclusion and 5 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 20 Oct 2015. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 Mar 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?

Number of Eyes With No Change in Corneal Staining (time frame: Change from baseline after 1, 2, 4 and 6+ hours of wear). 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 NCT01024855.

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 20 Oct 2015.