Dry EyeNCT02511379

Clinical Evaluation of Systane® Balance in Dry Eye Subjects

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Dry Eye
What is being tested?: Propylene Glycol 0.6% eye drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: No sites listed yet
Study dates: 26 Nov 2015to 20 Jun 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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign informed consent and willing and able to attend all study visits;
Dry eye in both eyes diagnosed by an ophthalmologist;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Women of childbearing potential who are pregnant or breastfeeding;
Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening;
Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects With Dry Eye

The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.

Read the detailed description

This study was conducted in India.

Conditions: Dry Eye
Being tested: Propylene Glycol 0.6% 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

Study groups in NCT02511379
Study group	Role	What they receive
Systane Balance	Experimental	Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days Receives: Other: Propylene Glycol 0.6% eye drops

What is being measured

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

Change From Baseline in Corneal Staining Total Score
The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).
Measured: Baseline (Day 0), Day 45, Day 90

Timeline

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

26 Nov 201520 Jun 2016

First posted30 Jul 2015 (estimated)
Study start26 Nov 2015
Primary completion20 Jun 2016
Study completion20 Jun 2016

Why it stopped: Discontinuation of product development

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02511379
Sponsor's protocol ID: EXJ821-P001 (C-13-039)
Other IDs: CTRI/2015/10/006320
Status last verified: Oct 2018
First submitted: 28 Jul 2015
Last updated: 31 Oct 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 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects With Dry Eye
ClinicalTrials.gov ID: NCT02511379
Acronym / sponsor ID: EXJ821-P001 (C-13-039)
Conditions: Dry Eye
Study type: Interventional
Recruitment status: TerminatedReason stopped: Discontinuation of product development
Enrolment: 14 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 26 Nov 2015 (actual)
Primary completion: 20 Jun 2016 (actual)
Study completion: 20 Jun 2016 (actual)
First posted: 30 Jul 2015 (estimated)
Results: Posted 5 Sep 2018

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 efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.

Detailed description

This study was conducted in India.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Systane Balance	Experimental	Other: Propylene Glycol 0.6% eye dropsPropylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Sign informed consent and willing and able to attend all study visits;
Dry eye in both eyes diagnosed by an ophthalmologist;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (7 listed)

Women of childbearing potential who are pregnant or breastfeeding;
Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening;
Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;

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

Primary outcome

Change From Baseline in Corneal Staining Total Score
Time frame: Baseline (Day 0), Day 45, Day 90
The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).

Results and safety

Results posted to the registry on 5 Sep 2018, 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	14	14

Primary outcome: Change From Baseline in Corneal Staining Total Score

Time frame: Baseline (Day 0), Day 45, Day 90. Mean (Full Range). Unit: units on a scale

Measure	Systane Balance n = 14
Change from baseline at Day 45	-3.1 (-8 to 1)
Change from baseline at Day 90	-4.8 (-11 to -1)

Population analysed: Analysis includes all participants with data present. Analysis was based on the eye with the higher corneal staining total score at screening or the right eye when both eyes have same corneal staining total score at screening, as observed.

Adverse events

Time frame: Adverse events were collected for the duration of participation, an average of 90 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Systane Balance	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Alcon Research, Ltd study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Propylene Glycol 0.6% 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 Oct 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 5 Sep 2018). 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 Corneal Staining Total Score (time frame: Baseline (Day 0), Day 45, Day 90). 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 NCT02511379.

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 31 Oct 2018.