Dry EyeNCT02470429

Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

A study testing SYSTANE HYDRATION lubricant eye drops, Hyabak 0.15% eye drops and 0.9% saline 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.

Official record

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Trial summary

The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42. 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 HYDRATION lubricant eye drops, Hyabak 0.15% eye drops and 0.9% saline eye drops
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: No sites listed yet
Study dates: 17 Jul 2015to 26 May 2016
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;
Use of non-BAK (Benzalkonium Chloride) artificial tears at least once a day, for at least 3 months prior to Screening Visit;
Diagnosis of Dry Eye (by a health care professional) for at least 3 months prior to Screening Visit;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Women of childbearing potential who are pregnant or breast feeding;
Any hypersensitivity to the use of the study products or an allergy to any ingredient(s) contained within study products;
Ocular abnormalities in either eye that could adversely affect the safety or efficacy outcome;
Active ocular infection (bacterial, viral, or fungal) or active inflammation not associated with dry eye;
Use of chronic systemic medications: (prescription, over the counter, vitamins/supplements) on a stable dose for less than 30 days prior to Screening Visit, or any anticipated change in dosing regimen during the course of the study;
History of ocular or intraocular surgery or serious ocular trauma in either eye within 6 months prior to Screening Visit;

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Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of study products or safe participation in the study;
Use of any topical ocular over-the-counter or prescribed medications in either eye (with the exception of artificial tears/gels/ lubricants) 2 weeks prior to Screening Visit;
Contact lens use within 2 weeks prior to Screening Visit and unwilling to avoid contact lens use during the course of the study;
Unwilling to avoid the use of additional artificial tears (other than the study products) throughout the study;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye

The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.

Read the detailed description

Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops) to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE® HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.

Conditions: Dry Eye
Being tested: SYSTANE HYDRATION lubricant eye drops, Hyabak 0.15% eye drops, 0.9% saline 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.

SYSTANE HYDRATION lubricant eye dropsDevice
Also called SYSTANE® HYDRATION
Preserved with POLYQUAD (polidronium chloride) 0.001%
Hyabak 0.15% eye dropsDevice
Also called Hyabak 0.15%
Preservative-free
0.9% saline eye dropsDrug
Preservative-free, one drop 4 times a day in each eye (run-in period)

Study groups in NCT02470429
Study group	Role	What they receive
SYSTANE HYDRATION	Experimental	SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days Receives: Device: SYSTANE HYDRATION lubricant eye drops; Drug: 0.9% saline eye drops
Hyabak 0.15%	Active comparator	Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days Receives: Device: Hyabak 0.15% eye drops; Drug: 0.9% saline eye drops

What is being measured

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

Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 0), Day 42

Secondary outcomes (3)

Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42
The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.
Measured: Baseline (Day 0), Day 42
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42
The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.
Measured: Baseline (Day 0), Day 42
Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42
TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms. One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 0), Day 42

Timeline

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

17 Jul 201526 May 2016

First posted12 Jun 2015 (estimated)
Study start17 Jul 2015
Primary completion26 May 2016
Study completion26 May 2016

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: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02470429
Sponsor's protocol ID: EXK947-P001
Status last verified: Jun 2017
First submitted: 10 Jun 2015
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye
ClinicalTrials.gov ID: NCT02470429
Acronym / sponsor ID: EXK947-P001
Conditions: Dry Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 17 Jul 2015 (actual)
Primary completion: 26 May 2016 (actual)
Study completion: 26 May 2016 (actual)
First posted: 12 Jun 2015 (estimated)
Results: Posted 16 Jun 2017

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 compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.

Detailed description

Study design

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

Arm	Type	Receives
SYSTANE HYDRATION	Experimental	Device: SYSTANE HYDRATION lubricant eye drops, Drug: 0.9% saline eye dropsSYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Hyabak 0.15%	Active comparator	Device: Hyabak 0.15% eye drops, Drug: 0.9% saline eye dropsHyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days

Who may qualify

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

Key inclusion criteria (4 listed)

Willing and able to attend all study visits;
Use of non-BAK (Benzalkonium Chloride) artificial tears at least once a day, for at least 3 months prior to Screening Visit;
Diagnosis of Dry Eye (by a health care professional) for at least 3 months prior to Screening Visit;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (11 listed)

Women of childbearing potential who are pregnant or breast feeding;
Any hypersensitivity to the use of the study products or an allergy to any ingredient(s) contained within study products;
Ocular abnormalities in either eye that could adversely affect the safety or efficacy outcome;
Active ocular infection (bacterial, viral, or fungal) or active inflammation not associated with dry eye;
Use of chronic systemic medications: (prescription, over the counter, vitamins/supplements) on a stable dose for less than 30 days prior to Screening Visit, or any anticipated change in dosing regimen during the course of the study;

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 HYDRATION lubricant eye dropsAlso: SYSTANE® HYDRATIONPreserved with POLYQUAD (polidronium chloride) 0.001%	Device	SYSTANE HYDRATION
Hyabak 0.15% eye dropsAlso: Hyabak 0.15%Preservative-free	Device	Hyabak 0.15%
0.9% saline eye dropsPreservative-free, one drop 4 times a day in each eye (run-in period)	Drug	Hyabak 0.15%, SYSTANE HYDRATION

Primary outcome

Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
Time frame: Baseline (Day 0), Day 42
The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.

3 secondary outcomes

Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42
Time frame: Baseline (Day 0), Day 42
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42
Time frame: Baseline (Day 0), Day 42
Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42
Time frame: Baseline (Day 0), Day 42

Results and safety

Results posted to the registry on 16 Jun 2017, 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 HYDRATION	50	48
Hyabak 0.15%	49	49

Primary outcome: Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42

Time frame: Baseline (Day 0), Day 42. Least squares mean (Standard Error). Unit: units on a scale

Measure	SYSTANE HYDRATION n = 48	Hyabak 0.15% n = 49
Value	-1.16 (0.24)	-0.92 (0.23)

Population analysed: ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 114 (0%)	2 of 114 (1.8%)	0 of 114
SYSTANE HYDRATION	1 of 50 (2%)	12 of 50 (24%)	0 of 50
Hyabak 0.15%	1 of 49 (2%)	6 of 49 (12.2%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 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.

Global Trial Leader, Global Development Operations study director

Alcon, A Novartis Division

Questions about this trial

What is this clinical trial studying?

A study testing SYSTANE HYDRATION lubricant eye drops, Hyabak 0.15% eye drops and 0.9% saline 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 4 inclusion and 11 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 Jul 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 16 Jun 2017). 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?

Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42 (time frame: Baseline (Day 0), Day 42). 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 NCT02470429.

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 Jul 2018.