Corneal StainingNCT01240122

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

A study testing Biotrue MPS and Investigational MPS in people with Corneal Staining, 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.

Official record

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Trial summary

An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue 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 years and olderHealthy volunteers can take part
Conditions the study is for: Corneal Staining
What is being tested?: Biotrue MPS and Investigational MPS
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: 31 Aug 2010to 30 Nov 2010
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
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

An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Conditions: Corneal Staining
Being tested: Biotrue MPS, Investigational MPS
Keywords: Corneal staining and comfort evaluation in normal, habitual contact lens wearers.

What participants receive

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

Biotrue MPSDevice
Multi-purpose contact lens care solution
Investigational MPSDevice
Multi-purpose contact lens care solution

Study groups in NCT01240122
Study group	Role	What they receive
Biotrue MPS	Active comparator	Not described Receives: Device: Biotrue MPS
Investigational MPS	Experimental	Not described Receives: Device: Investigational MPS

What is being measured

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

Corneal Staining by Wear Time
All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.
Measured: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4

Secondary outcomes (2)

Subjective Solution Preference
All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference.
Measured: Day 4
Overall Ocular Comfort
All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.
Measured: Day 4

Timeline

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

31 Aug 201030 Nov 2010

First posted15 Nov 2010 (estimated)
Study start31 Aug 2010
Primary completion30 Nov 2010
Study completion30 Nov 2010

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 Corneal StainingStudies 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: Other
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01240122
Sponsor's protocol ID: COBR-109-9608
Status last verified: Feb 2025
First submitted: 8 Nov 2010
Last updated: 3 Mar 2025
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

Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
RecruitingPhase 4
Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
Meibomian Gland Dysfunction (MGD)
Not yet recruiting
Eyelid Taping Alone Versus Taping With Lubricant Eye Drops for Perioperative Corneal Protection
Corneal Injury, Exposure Keratopathy
Enrolling by invitationPhase 4
Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye
Dry Eye Disease (DED), Tear Break-Up Time

All Corneal Staining trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
ClinicalTrials.gov ID: NCT01240122
Acronym / sponsor ID: COBR-109-9608
Conditions: Corneal Staining
Keywords: Corneal staining and comfort evaluation in normal, habitual contact lens wearers.
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Abbott Medical OpticsIndustry (pharma, biotech, devices)
Study start: 31 Aug 2010 (actual)
Primary completion: 30 Nov 2010 (actual)
Study completion: 30 Nov 2010 (actual)
First posted: 15 Nov 2010 (estimated)
Results: Posted 11 Jun 2012

Clinical summary

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

An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Biotrue MPS	Active comparator	Device: Biotrue MPS
Investigational MPS	Experimental	Device: Investigational MPS

Who may qualify

Ages: 18 years and older
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
Biotrue MPSMulti-purpose contact lens care solution	Device	Biotrue MPS
Investigational MPSMulti-purpose contact lens care solution	Device	Investigational MPS

Primary outcome

Corneal Staining by Wear Time
Time frame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4
All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.

2 secondary outcomes

Subjective Solution Preference
Time frame: Day 4
Overall Ocular Comfort
Time frame: Day 4

Results and safety

Results posted to the registry on 11 Jun 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
Biotrue/Investigational MPS	29	29

Primary outcome: Corneal Staining by Wear Time

Time frame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4. Number. Unit: participants

Measure	Biotrue n = 29	Investigational MPS n = 29
Staining at 1 Hour, Day 1	19	15
Staining at 2 Hours, Day 2	19	7
Staining at 4 Hours, Day 3	21	5
Staining at End of Day, Day 4	18	8

Population analysed: Corneal Staining Severity at Scheduled Visits (Safety Population)

2 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
Biotrue/Investigational MPS	0 of 29 (0%)	0 of 29 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Corneal Staining

Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
RecruitingPhase 4
Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
Meibomian Gland Dysfunction (MGD)
Not yet recruiting
Eyelid Taping Alone Versus Taping With Lubricant Eye Drops for Perioperative Corneal Protection
Corneal Injury, Exposure Keratopathy
Enrolling by invitationPhase 4
Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye
Dry Eye Disease (DED), Tear Break-Up Time

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.

Eugenia Y Kao, OD principal investigator

AMO

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

Questions about this trial

What is this clinical trial studying?

A study testing Biotrue MPS and Investigational MPS in people with Corneal Staining, 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 3 Mar 2025. 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 11 Jun 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?

Corneal Staining by Wear Time (time frame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4). 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 NCT01240122.

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 3 Mar 2025.