Dry Eye SyndromeNCT01733732

SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers

A study testing SYSTANE® BALANCE Lubricant Eye Drops and SYSTANE® Gel in people with Dry Eye Syndrome, 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 ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome
What is being tested?: SYSTANE® BALANCE Lubricant Eye Drops and SYSTANE® Gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: No sites listed yet
Study dates: Mar 2013to Oct 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

Read, sign, and date the Informed Consent Document;
Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);
Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes;
Other protocol-defined inclusion criteria may apply.

Who cannot join

History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months;
Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
Use of any concomitant topical ocular medications during the study period;
Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire study period;
Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1 and that remains stable throughout the study;
Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular condition that may preclude the safe administration of either drop under investigation;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Study to Evaluate the Efficacy of SYSTANE® BALANCE in Reducing Symptoms and Inflammatory Biomarker Expression of HLA-DR and Tear Film Cytokines in Dry Eye Subjects With Lipid Deficiency

The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.

Conditions: Dry Eye Syndrome
Being tested: SYSTANE® BALANCE Lubricant Eye Drops, SYSTANE® Gel
Keywords: Dry eye, Lipid deficiency, Inflammatory markers
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 Lubricant Eye DropsOther
Also called SYSTANE® BALANCE
SYSTANE® GelOther

Study groups in NCT01733732
Study group	Role	What they receive
Systane Balance	Experimental	SYSTANE® BALANCE Lubricant Eye Drops, 1 drop in each eye 4 times a day for 30 days Receives: Other: SYSTANE® BALANCE Lubricant Eye Drops
Systane Gel	Active comparator	SYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days Receives: Other: SYSTANE® Gel

What is being measured

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

Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit
The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.
Measured: Baseline (Day 0), Day 14, Day 30

Secondary outcomes (11)

Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit
BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean.
Measured: Baseline (Day 0), Day 14, Day 30
Percentage of Eyes With Normal Slit-lamp Assessment
An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation.
Measured: Baseline (Day 0), Day 14, Day 30
Meibomian Gland Expression
Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean.
Measured: Baseline (Day 0), Day 14, Day 30
Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit
NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.
Measured: Baseline (Day 0), Day 14, Day 30
Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.
Measured: Baseline (Day 0), Day 14, Day 30
Mean Change From Baseline in Ocular Surface Staining by Visit
Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.
Measured: Baseline (Day 0), Day 14, Day 30
Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30
A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.
Measured: Baseline (Day 0), Day 30
Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30
Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.
Measured: Baseline (Day 0), Day 30
Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30
Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.
Measured: Baseline (Day 0), Day 30
Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit
Dry eye status was assessed using the Schirmer's test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.
Measured: Baseline (Day 0), Day 14, Day 30
Mean Change From Baseline in Intraocular Pressure (IOP) by Visit
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean.
Measured: Baseline (Day 0), Day 14, Day 30

Timeline

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

Mar 2013Oct 2013

First posted27 Nov 2012 (estimated)
Study startMar 2013
Primary completionOct 2013
Study completionOct 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.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01733732
Sponsor's protocol ID: A00976
Status last verified: Nov 2013
First submitted: 21 Nov 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: Study to Evaluate the Efficacy of SYSTANE® BALANCE in Reducing Symptoms and Inflammatory Biomarker Expression of HLA-DR and Tear Film Cytokines in Dry Eye Subjects With Lipid Deficiency
ClinicalTrials.gov ID: NCT01733732
Acronym / sponsor ID: A00976
Conditions: Dry Eye Syndrome
Keywords: Dry eye, Lipid deficiency, Inflammatory markers
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 27 Nov 2012 (estimated)
Results: Posted 4 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 ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.

Study design

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

Arm	Type	Receives
Systane Balance	Experimental	Other: SYSTANE® BALANCE Lubricant Eye DropsSYSTANE® BALANCE Lubricant Eye Drops, 1 drop in each eye 4 times a day for 30 days
Systane Gel	Active comparator	Other: SYSTANE® GelSYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days

Who may qualify

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

Key inclusion criteria (5 listed)

Read, sign, and date the Informed Consent Document;
Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);
Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (8 listed)

History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months;
Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
Use of any concomitant topical ocular medications during the study period;
Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire study period;

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 Lubricant Eye DropsAlso: SYSTANE® BALANCE	Other	Systane Balance
SYSTANE® Gel	Other	Systane Gel

Primary outcome

Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit
Time frame: Baseline (Day 0), Day 14, Day 30
The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.

11 secondary outcomes

Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit
Time frame: Baseline (Day 0), Day 14, Day 30
Percentage of Eyes With Normal Slit-lamp Assessment
Time frame: Baseline (Day 0), Day 14, Day 30
Meibomian Gland Expression
Time frame: Baseline (Day 0), Day 14, Day 30
Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit
Time frame: Baseline (Day 0), Day 14, Day 30
Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit
Time frame: Baseline (Day 0), Day 14, Day 30
Mean Change From Baseline in Ocular Surface Staining by Visit
Time frame: Baseline (Day 0), Day 14, Day 30
Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30
Time frame: Baseline (Day 0), Day 30
Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30
Time frame: Baseline (Day 0), Day 30
Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30
Time frame: Baseline (Day 0), Day 30
Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit
Time frame: Baseline (Day 0), Day 14, Day 30
Mean Change From Baseline in Intraocular Pressure (IOP) by Visit
Time frame: Baseline (Day 0), Day 14, Day 30

Results and safety

Results posted to the registry on 4 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	27	25
Systane Gel	27	27

Primary outcome: Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit

Time frame: Baseline (Day 0), Day 14, Day 30. Mean (Standard Deviation). Unit: units on a scale

Measure	Systane Balance n = 27	Systane Gel n = 27
Change from baseline at Day 14, n=25, 27	-7.85 (18.19)	-12.58 (19.05)
Change from baseline at Day 30, n=27, 27	-10.23 (21.72)	-16.74 (21.13)

Population analysed: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (7 months). This analysis group includes all subjects exposed to the test product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Systane Balance	0 of 27 (0%)	0 of 27 (0%)	Not reported
Systane Gel	1 of 27 (3.7%)	0 of 27 (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.

Related trials for Dry Eye Syndrome

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RecruitingObservational study
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Not yet recruitingPhase 2
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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.

Abayomi Ogundele, PharmD study director

Alcon Research

Penny A. Asbell, MD principal investigator

Icahn School of Medicine at Mount Sinai

Questions about this trial

What is this clinical trial studying?

A study testing SYSTANE® BALANCE Lubricant Eye Drops and SYSTANE® Gel in people with Dry Eye Syndrome, 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 5 inclusion and 8 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 4 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?

Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit (time frame: Baseline (Day 0), Day 14, Day 30). 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 NCT01733732.

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.