Dry Eye SyndromeM-12-077NCT01733745

SYSTANE® Family - Meibomian Deficiency

A study testing SYSTANE® Lid Wipes, SYSTANE® BALANCE and SYSTANE® Vitamins 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 was to assess the efficacy of the SYSTANE® family of products (SYSTANE® Lid Wipes, SYSTANE® BALANCE Lubricant Eye Drops, and SYSTANE® Vitamins) on meibomian gland functionality in subjects with lipid deficiency related to evaporative dry eye as compared to the standard of care warm compresses. 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® Lid Wipes, SYSTANE® BALANCE and SYSTANE® Vitamins
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: No sites listed yet
Study dates: Feb 2013to Jun 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

Must have a clinical diagnosis of lipid deficient Evaporative Dry Eye;
Meibomian Gland Functionality - Not more than 6 glands yielding liquid secretion;
Must be willing to discontinue the use of all other Meibomian Gland; Dysfunction management prior to receiving the study test article at Visit 1, up until the end of the study period;
Must have best corrected visual acuity of 20/40 Snellen or better in each eye;
Must be able to follow instructions and be willing and able to attend required study visits;
Must read, sign, and date an Ethics Committee reviewed and approved informed consent form;
Other protocol-defined inclusion criteria may apply.

Who cannot join

History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months;
Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
History of intolerance or hypersensitivity to any component of the study medications;
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;
Pregnant or lactating at the time of enrollment;
Not willing to take adequate precautions not to become pregnant during the study;

Show all 12Show fewer

Use of any concomitant topical ocular medications during the 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;
Ocular conditions that may preclude the safe administration of either drop under investigation;
Unwilling to discontinue contact lens wear during the study period and for at least 1 week prior to Visit 1;
Participation in an investigational drug or device study within 30 days of entering this study;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: SYSTANE® Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects

Conditions: Dry Eye Syndrome
Being tested: SYSTANE® Lid Wipes, SYSTANE® BALANCE, SYSTANE® Vitamins, Microfiber towels (as warm compresses, with or without saline eye drops)
Keywords: dry eye, lipid deficiency, meibomian gland
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® Lid WipesOther
Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
SYSTANE® BALANCEOther
Lubricant Eye Drops
SYSTANE® VitaminsDietary supplement
Also called SYSTANE® Vitamin Omega-3 Supplement
Microfiber towels (as warm compresses, with or without saline eye drops)Other

Study groups in NCT01733745
Study group	Role	What they receive
SYSTANE® Family	Experimental	SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months. Receives: Other: SYSTANE® Lid Wipes; Other: SYSTANE® BALANCE; Dietary Supplement: SYSTANE® Vitamins
Standard of Care	Active comparator	Microfiber towels (as warm compresses, with or without saline eye drops) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months. Receives: Other: Microfiber towels (as warm compresses, with or without saline eye drops)

What is being measured

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

Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)
Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.
Measured: Baseline, Month 1, Month 2, Month 3

Secondary outcomes (2)

Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses
The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.
Measured: Baseline, Month 1, Month 2, Month 3
Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses
The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.
Measured: Baseline, Month 1, Month 2, Month 3

Timeline

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

Feb 2013Jun 2013

First posted27 Nov 2012 (estimated)
Study startFeb 2013
Primary completionJun 2013
Study completionJun 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: Single blind
Who is masked: Investigator
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01733745
Sponsor's protocol ID: A00978
Acronym: M-12-077
Status last verified: Sep 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: SYSTANE® Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects
ClinicalTrials.gov ID: NCT01733745
Acronym / sponsor ID: M-12-077 / A00978
Conditions: Dry Eye Syndrome
Keywords: dry eye, lipid deficiency, meibomian gland
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 27 Nov 2012 (estimated)
Results: Posted 3 Jul 2014

Clinical summary

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

Study design

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

Arm	Type	Receives
SYSTANE® Family	Experimental	Other: SYSTANE® Lid Wipes, Other: SYSTANE® BALANCE, Dietary Supplement: SYSTANE® VitaminsSYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
Standard of Care	Active comparator	Other: Microfiber towels (as warm compresses, with or without saline eye drops)Microfiber towels (as warm compresses, with or without saline eye drops) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.

Who may qualify

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

Key inclusion criteria (7 listed)

Must have a clinical diagnosis of lipid deficient Evaporative Dry Eye;
Meibomian Gland Functionality - Not more than 6 glands yielding liquid secretion;
Must be willing to discontinue the use of all other Meibomian Gland; Dysfunction management prior to receiving the study test article at Visit 1, up until the end of the study period;
Must have best corrected visual acuity of 20/40 Snellen or better in each eye;
Must be able to follow instructions and be willing and able to attend required study visits;

Key exclusion criteria (12 listed)

History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months;
Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
History of intolerance or hypersensitivity to any component of the study medications;
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;
Pregnant or lactating at the time of enrollment;

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® Lid WipesPre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes	Other	SYSTANE® Family
SYSTANE® BALANCELubricant Eye Drops	Other	SYSTANE® Family
SYSTANE® VitaminsAlso: SYSTANE® Vitamin Omega-3 Supplement	Dietary supplement	SYSTANE® Family
Microfiber towels (as warm compresses, with or without saline eye drops)	Other	Standard of Care

Primary outcome

Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)
Time frame: Baseline, Month 1, Month 2, Month 3
Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.

2 secondary outcomes

Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses
Time frame: Baseline, Month 1, Month 2, Month 3
Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses
Time frame: Baseline, Month 1, Month 2, Month 3

Results and safety

Results posted to the registry on 3 Jul 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® Family	13	13
Standard of Care	13	13

Primary outcome: Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)

Time frame: Baseline, Month 1, Month 2, Month 3. Mean (Standard Deviation). Unit: functioning glands

Measure	SYSTANE® Family n = 13	Standard of Care n = 13
Baseline	3.5 (1.50)	4.2 (1.39)
Month 1	7.0 (3.12)	3.9 (1.76)
Month 2	6.4 (2.45)	3.5 (1.90)
Month 3	9.3 (2.72)	4.7 (2.29)

Population analysed: This reporting group includes all subjects who were enrolled and received at least one of the study treatments.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (4 months). This analysis group includes all enrolled and exposed subjects.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SYSTANE® Family	0 of 13 (0%)	1 of 13 (7.7%)	Not reported
Standard of Care	0 of 13 (0%)	0 of 13 (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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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.

Danyel C. Carr, MS, CCRA study director

Alcon Research

Donald R Korb, O.D. principal investigator

Korb and Associates

Questions about this trial

What is this clinical trial studying?

A study testing SYSTANE® Lid Wipes, SYSTANE® BALANCE and SYSTANE® Vitamins 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 7 inclusion and 12 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 3 Jul 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?

Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) (time frame: Baseline, Month 1, Month 2, Month 3). 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 NCT01733745.

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.