Dry EyeNCT02776670

Clinical Outcomes Following Treatment With SYSTANE® BALANCE

A study testing Propylene glycol, 0.6% eye drops and Lubricant eye drops in people with Dry Eye, run by Alcon Research.

Completed

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

Trial summary

The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye. 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?: Propylene glycol, 0.6% eye drops and Lubricant eye drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 308 participants
Where: No sites listed yet
Study dates: 29 Jul 2016to 22 Nov 2017
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

Willing and able to attend all study visits;
Must sign an informed consent form;
Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
Willing to take study products as directed for entire study;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
Use of medication excluded by the protocol;
Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
Ocular surgeries or procedures excluded by the protocol;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Clinical Evaluation Following Use of SYSTANE® BALANCE in Subjects With Lipid-Deficient Dry Eye

The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.

Conditions: Dry Eye
Being tested: Propylene glycol, 0.6% eye drops, Lubricant eye drops
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.

Propylene glycol, 0.6% eye dropsOther
Also called SYSTANE® BALANCE
Lubricant eye dropsOther
Also called REFRESH OPTIVE® Advanced

Study groups in NCT02776670
Study group	Role	What they receive
SYSTANE BALANCE	Experimental	Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days Receives: Other: Propylene glycol, 0.6% eye drops
REFRESH OPTIVE	Active comparator	Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days Receives: Other: Lubricant eye drops

What is being measured

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

Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.
Measured: Baseline (Day 0), Day 35

Secondary outcomes (3)

Change From Baseline in TFBUT at Day 35
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.
Measured: Baseline (Day 0), Day 35
Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35
LLT was measured using the LipiView® Ocular Surface Interferometer, an ophthalmic imaging device intended for use in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. Using these images, the LipiView® Interferometer measures the absolute thickness of the tear film lipid layer.
Measured: Day 35
Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35
Ocular discomfort frequency and severity (each graded on a separate 100-units scale) were assessed using a visual analog scale (VAS). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past week' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past week' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for the given visit, as the square root of the product of the ocular discomfort frequency score multiplied by the ocular discomfort severity score. Improvement results in a reduction of the ocular discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.
Measured: Baseline (Day 0), Day 35

Timeline

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

29 Jul 201622 Nov 2017

First posted18 May 2016 (estimated)
Study start29 Jul 2016
Primary completion22 Nov 2017
Study completion22 Nov 2017

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 308 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02776670
Sponsor's protocol ID: EXB107-P001
Status last verified: Mar 2019
First submitted: 17 May 2016
Last updated: 19 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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 trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation Following Use of SYSTANE® BALANCE in Subjects With Lipid-Deficient Dry Eye
ClinicalTrials.gov ID: NCT02776670
Acronym / sponsor ID: EXB107-P001
Conditions: Dry Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 308 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 29 Jul 2016 (actual)
Primary completion: 22 Nov 2017 (actual)
Study completion: 22 Nov 2017 (actual)
First posted: 18 May 2016 (estimated)
Results: Posted 19 Jun 2019

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 clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.

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: Propylene glycol, 0.6% eye dropsPropylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
REFRESH OPTIVE	Active comparator	Other: Lubricant eye dropsLubricant eye drops, 1 drop in each eye 4 times per day for 35 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)

Willing and able to attend all study visits;
Must sign an informed consent form;
Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
Willing to take study products as directed for entire study;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (6 listed)

Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
Use of medication excluded by the protocol;
Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
Ocular surgeries or procedures excluded by the protocol;

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
Propylene glycol, 0.6% eye dropsAlso: SYSTANE® BALANCE	Other	SYSTANE BALANCE
Lubricant eye dropsAlso: REFRESH OPTIVE® Advanced	Other	REFRESH OPTIVE

Primary outcome

Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35
Time frame: Baseline (Day 0), Day 35
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.

3 secondary outcomes

Change From Baseline in TFBUT at Day 35
Time frame: Baseline (Day 0), Day 35
Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35
Time frame: Day 35
Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35
Time frame: Baseline (Day 0), Day 35

Results and safety

Results posted to the registry on 19 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

The registry did not answer just now, so the posted figures can't be shown here. Open the results on ClinicalTrials.gov.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Dry Eye

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland

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.

Clinical Project Manager, PLS study director

Alcon, a Novartis Company

Questions about this trial

What is this clinical trial studying?

A study testing Propylene glycol, 0.6% eye drops and Lubricant eye drops in people with Dry Eye, 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 6 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 19 Jun 2019. 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 19 Jun 2019). 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 Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35 (time frame: Baseline (Day 0), Day 35). 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 NCT02776670.

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 19 Jun 2019.