Dry EyeNCT02380248

Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

A study testing Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops in people with Dry Eye, run by Alcon Research at 1 site in India.

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 efficacy and safety of Systane® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing. 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?: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 207 participants
Where: 1 siteIndia
Study dates: 14 May 2015to 1 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

Must give informed consent, and be willing and able to attend all study visits.
Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method).
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, test positive on a pregnancy test, or breast-feeding.
Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study.
Any contraindications or hypersensitivities to the study medications or their components.
Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) 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.
Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening.

Show all 9Show fewer

Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study.
Participation in any other clinical trial within 30 days prior to Screening.
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

India1 site

Contact Alcon India for Trial Locations
Karnataka, 560048

Other trials in India

About this study

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

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

Conditions: Dry Eye
Being tested: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% 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.

Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye dropsOther
Also called Systane® Gel Drops

Study groups in NCT02380248
Study group	Role	What they receive
Systane	Experimental	Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days Receives: Other: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% 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 at All Study Time Points
Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.
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.

14 May 20151 Jun 2016

First posted5 Mar 2015 (estimated)
Study start14 May 2015
Primary completion1 Jun 2016
Study completion1 Jun 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02380248
Sponsor's protocol ID: EXI639-P001 (C-13-040)
Status last verified: May 2017
First submitted: 2 Mar 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?

See locations

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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: Clinical Evaluation of Systane® Gel Drops on Corneal Staining in Indian Subjects With Dry Eye
ClinicalTrials.gov ID: NCT02380248
Acronym / sponsor ID: EXI639-P001 (C-13-040)
Conditions: Dry Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 14 May 2015 (actual)
Primary completion: 1 Jun 2016 (actual)
Study completion: 1 Jun 2016 (actual)
First posted: 5 Mar 2015 (estimated)
Results: Posted 5 May 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 evaluate the efficacy and safety of Systane® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.

Study design

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

Arm	Type	Receives
Systane	Experimental	Other: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye dropsPolyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID 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 (4 listed)

Must give informed consent, and be willing and able to attend all study visits.
Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method).
Dry eye in both eyes diagnosed by an ophthalmologist.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (9 listed)

Women of childbearing potential who are pregnant, test positive on a pregnancy test, or breast-feeding.
Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study.
Any contraindications or hypersensitivities to the study medications or their components.
Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) 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.

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
Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye dropsAlso: Systane® Gel Drops	Other	Systane

Primary outcome

Change From Baseline in Corneal Staining at All Study Time Points
Time frame: Baseline (Day 0), Day 45, Day 90
Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.

Results and safety

Results posted to the registry on 5 May 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	200	186

Primary outcome: Change From Baseline in Corneal Staining at All Study Time Points

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

Measure	Systane n = 190
Change from baseline at Day 45	-2.7 (0.14)
Change from baseline at Day 90	-4.0 (0.16)

Population analysed: Full Analysis Set. Number analyzed includes number of subjects with non-missing response in specified category.

Adverse events

Time frame: Adverse Events (AEs) were collected from the time of informed consent for the duration of a subject's participation in the study (up to 90 days). AEs are reported as pre-treatment and treatment-emergent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 207 (0%)	0 of 207 (0%)	0 of 207
Systane	0 of 200 (0%)	0 of 200 (0%)	0 of 200

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.

Head, CTM, Med Affairs study director

Alcon Laboratories Pvt Ltd (India)

Sr. Clinical Manager, Global Trial Leadership study director

Alcon, A Novartis Division

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops in people with Dry Eye, run by Alcon Research at 1 site in India.

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 9 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.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

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 May 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 Corneal Staining at All Study Time Points (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 NCT02380248.

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.