Dry EyeNCT00702377

Evaluation of SYSTANE Ultra Lubricant Eye Drops

A study testing SYSTANE Ultra and Optive in people with Dry Eye, 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

To evaluate the safety and efficacy of two artificial tears in dry eye patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye
What is being tested?: SYSTANE Ultra and Optive
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 1 siteUnited States
Study dates: Jun 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

Documented diagnosis of dry eyes
Must not have worn contact lenses for 1 week preceding enrollment

Who cannot join

Age related

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Call Center for Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

To evaluate the safety and efficacy of two artificial tears in dry eye patients.

Conditions: Dry Eye
Being tested: SYSTANE Ultra, Optive
Medical subject headings: Dry Eye Syndromes

What participants receive

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

SYSTANE UltraOther
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
OptiveOther
Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days

Study groups in NCT00702377
Study group	Role	What they receive
SYSTANE Ultra	Experimental	SYSTANE Ultra Lubricant Eye Drops Receives: Other: SYSTANE Ultra
OPTIVE	Active comparator	OPTIVE Lubricant Eye Drops Receives: Other: Optive

What is being measured

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

Tear Break-up Time
Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
Measured: Day 0, Day 7, Day 14, Day 28, and Day 42
Conjunctival Staining
Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.
Measured: Day 0, Day 7, Day 14, Day 28, Day 42
Corneal Staining
Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.
Measured: Day 0, Day 7, Day 14, Day 28, Day 42

Timeline

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

Jun 2008Sep 2008

First posted20 Jun 2008 (estimated)
Study startJun 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 Dry EyeStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00702377
Sponsor's protocol ID: C-07-33
Status last verified: Jan 2012
First submitted: 19 Jun 2008
Last updated: 2 Feb 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 Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of SYSTANE Ultra Lubricant Eye Drops
ClinicalTrials.gov ID: NCT00702377
Acronym / sponsor ID: C-07-33
Conditions: Dry Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 20 Jun 2008 (estimated)
Results: Posted 10 Feb 2010

Clinical summary

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

To evaluate the safety and efficacy of two artificial tears in dry eye patients.

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
SYSTANE Ultra	Experimental	Other: SYSTANE UltraSYSTANE Ultra Lubricant Eye Drops
OPTIVE	Active comparator	Other: OptiveOPTIVE Lubricant Eye Drops

Who may qualify

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

Key inclusion criteria (2 listed)

Documented diagnosis of dry eyes
Must not have worn contact lenses for 1 week preceding enrollment

Key exclusion criteria (1 listed)

Age related

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
SYSTANE UltraSYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days	Other	SYSTANE Ultra
OptiveOptive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days	Other	OPTIVE

Primary outcome

Tear Break-up Time
Time frame: Day 0, Day 7, Day 14, Day 28, and Day 42
Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
Conjunctival Staining
Time frame: Day 0, Day 7, Day 14, Day 28, Day 42
Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.
Corneal Staining
Time frame: Day 0, Day 7, Day 14, Day 28, Day 42
Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.

Results and safety

Results posted to the registry on 10 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SYSTANE Ultra	53	52
OPTIVE Lubricant Eye Drops	56	53

Primary outcome: Tear Break-up Time

Time frame: Day 0, Day 7, Day 14, Day 28, and Day 42. Mean (Standard Deviation). Unit: seconds

Measure	SYSTANE Ultra n = 53	OPTIVE Lubricant Eye Drops n = 56
Day 0	4.2 (1.9)	4.5 (2.3)
Day 7	4.7 (2.8)	4.2 (1.8)
Day 14	4.8 (2.8)	4.2 (1.8)
Day 28	4.6 (2.6)	5.2 (3.2)
Day 42	4.5 (2.3)	4.2 (2.3)

Primary outcome: Conjunctival Staining

Time frame: Day 0, Day 7, Day 14, Day 28, Day 42. Mean (Standard Deviation). Unit: Units on a scale

Measure	SYSTANE Ultra n = 53	OPTIVE Lubricant Eye Drops n = 56
Day 0	2.3 (1.1)	2.8 (1.4)
Day 7	2.1 (1.1)	2.5 (1.3)
Day 14	2.0 (1.2)	2.2 (1.4)
Day 28	1.9 (1.1)	2.4 (1.5)
Day 42	1.9 (1.0)	2.7 (1.4)

Primary outcome: Corneal Staining

Time frame: Day 0, Day 7, Day 14, Day 28, Day 42. Mean (Standard Deviation). Unit: Units on a scale

Measure	SYSTANE Ultra n = 53	OPTIVE Lubricant Eye Drops n = 56
Day 0	4.8 (1.8)	5.3 (2.5)
Day 7	3.6 (2.2)	4.3 (3.0)
Day 14	2.9 (2.1)	4.5 (2.9)
Day 28	3.1 (2.1)	3.8 (2.6)
Day 42	2.9 (1.8)	4.2 (2.8)

Adverse events

Time frame: From Day 0 to Day 42.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SYSTANE Ultra	0 of 53 (0%)	3 of 53 (5.7%)	Not reported
OPTIVE Lubricant Eye Drops	0 of 56 (0%)	0 of 56 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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.

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

Questions about this trial

What is this clinical trial studying?

A study testing SYSTANE Ultra and Optive in people with Dry Eye, 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 2 inclusion and 1 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 2 Feb 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 10 Feb 2010). 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?

Tear Break-up Time (time frame: Day 0, Day 7, Day 14, Day 28, and Day 42). 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 NCT00702377.

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 2 Feb 2012.