Dry Eye SyndromeNCT01688726

Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency

A study testing SYSTANE® BALANCE eyedrops and Minims® Saline 0.9% eyedrops in people with Dry Eye Syndrome and Lipid Deficiency, run by Alcon Research.

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 evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome, Lipid Deficiency
What is being tested?: SYSTANE® BALANCE eyedrops and Minims® Saline 0.9% eyedrops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: No sites listed yet
Study dates: Dec 2012to Nov 2013
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

Non-contact lens wearer;
Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
Lipid deficiency;
Best visual acuity of 6/9 or better in each eye;
Willingness to adhere to the instructions set in the clinical protocol;
Signature of the subject informed consent form;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Use of systemic medication which might produce dry eye side effects;
Systemic disease which might produce dry eye side effects;
Active or recent ocular inflammation or infection;
Use of ocular medication;
Significant ocular anomaly;
Previous ocular surgery;

Show all 10Show fewer

Previous use of Restasis;
Any medical condition that might be prejudicial to the study;
Pregnant or lactating;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency

The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.

Conditions: Dry Eye Syndrome, Lipid Deficiency
Being tested: SYSTANE® BALANCE eyedrops, Minims® Saline 0.9% eyedrops
Keywords: Dry eye, Ocular surface, Vision complaint, Tear film stability, Time controlled functional visual acuity, Tear film kinetics
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® BALANCE eyedropsOther
Minims® Saline 0.9% eyedropsOther

Study groups in NCT01688726
Study group	Role	What they receive
SYSTANE BALANCE	Experimental	SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month Receives: Other: SYSTANE® BALANCE eyedrops
Minims Saline	Active comparator	Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month Receives: Other: Minims® Saline 0.9% eyedrops

What is being measured

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

Mean Bulbar Conjunctival Staining
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
Measured: Month 1

Secondary outcomes (2)

High Contrast logMAR Time Controlled Visual Acuity (TCVA)
TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
Measured: Month 1
Non Invasive Tear Film Break-up-time (NIBUT)
NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.
Measured: Month 1

Timeline

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

Dec 2012Nov 2013

First posted20 Sep 2012 (estimated)
Study startDec 2012
Primary completionNov 2013
Study completionNov 2013

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 Eye SyndromeStudies 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: Single blind
Who is masked: Investigator
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01688726
Sponsor's protocol ID: A00977
Status last verified: Aug 2014
First submitted: 17 Sep 2012
Last updated: 29 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?

Official record

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency
ClinicalTrials.gov ID: NCT01688726
Acronym / sponsor ID: A00977
Conditions: Dry Eye Syndrome, Lipid Deficiency
Keywords: Dry eye, Ocular surface, Vision complaint, Tear film stability, Time controlled functional visual acuity, Tear film kinetics
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 20 Sep 2012 (estimated)
Results: Posted 18 Nov 2014

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 evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
SYSTANE BALANCE	Experimental	Other: SYSTANE® BALANCE eyedropsSYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
Minims Saline	Active comparator	Other: Minims® Saline 0.9% eyedropsMinims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month

Who may qualify

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

Key inclusion criteria (7 listed)

Non-contact lens wearer;
Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
Lipid deficiency;
Best visual acuity of 6/9 or better in each eye;
Willingness to adhere to the instructions set in the clinical protocol;

Key exclusion criteria (10 listed)

Use of systemic medication which might produce dry eye side effects;
Systemic disease which might produce dry eye side effects;
Active or recent ocular inflammation or infection;
Use of ocular medication;
Significant ocular anomaly;

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® BALANCE eyedrops	Other	SYSTANE BALANCE
Minims® Saline 0.9% eyedrops	Other	Minims Saline

Primary outcome

Mean Bulbar Conjunctival Staining
Time frame: Month 1
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.

2 secondary outcomes

High Contrast logMAR Time Controlled Visual Acuity (TCVA)
Time frame: Month 1
Non Invasive Tear Film Break-up-time (NIBUT)
Time frame: Month 1

Results and safety

Results posted to the registry on 18 Nov 2014, 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 BALANCE	46	45
Minims Saline	45	44

Primary outcome: Mean Bulbar Conjunctival Staining

Time frame: Month 1. Mean (Standard Deviation). Unit: percentage of staining

Measure	SYSTANE BALANCE n = 45	Minims Saline n = 44
Right eye	0.743 (1.685)	0.442 (0.999)
Left eye	0.531 (1.056)	0.443 (1.404)

Population analysed: This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (Dec2012 to Nov2013). This analysis population includes all subjects who were randomized into the study, used at least 1 eye drop, and completed at least 1 post-treatment safety assessment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SYSTANE BALANCE	1 of 46 (2.2%)	0 of 46 (0%)	Not reported
Minims Saline	1 of 45 (2.2%)	0 of 45 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
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RecruitingObservational study
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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.

Michel Guillon, PhD, FCOptom, FAAO, CCTI principal investigator

OTG Research & Consultancy

Questions about this trial

What is this clinical trial studying?

A study testing SYSTANE® BALANCE eyedrops and Minims® Saline 0.9% eyedrops in people with Dry Eye Syndrome and Lipid Deficiency, run by Alcon Research.

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 10 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 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

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 18 Nov 2014). 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?

Mean Bulbar Conjunctival Staining (time frame: Month 1). 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 NCT01688726.

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 29 Jun 2018.