Dry Eye DiseaseNCT03492541
Study of Efficacy and Tolerability of SYSTANE Complete in Patients With Dry Eye Disease
A study testing Propylene glycol-based eye drops in people with Dry Eye Disease, run by Alcon Research at 5 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Propylene glycol-based eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 18 Jul 2018to 14 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 TFBUT of ≤ 5 seconds in at least one eye at Screening visit.
- Must have best corrected visual acuity (BCVA) of ≥ 20/80 (or ≥ 55 letters score or ≥ 0.6 early treatment diabetic retinopathy study (ETDRS) log of the minimum angle of resolution (LogMAR) value) in both eyes at the Screening visit.
- Must be willing to discontinue use of all artificial tear supplements and use only the study product as directed for the entire study duration.
Who cannot join
- History of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes.
- Use of any topical ocular medication preserved with benzalkonium chloride or other products known to be toxic to the tear film lipid layer within 1 month prior to the Screening visit.
- Other protocol-specified inclusion and exclusion criteria may apply.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Investigative Site
Kansas City, Missouri, 64133
Investigative Site
Kansas City, Missouri, 64155
Investigative Site
Norfolk, Virginia, 23502
About this study
Official title: Evaluation of the Clinical Efficacy and Tolerability of SYSTANE Complete in Adult Patients With Dry Eye Disease Following Topical Ocular Use for 4 Weeks: A Multicenter Trial
The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective.
Read the detailed description
Patients will attend 4 scheduled visits: Screening Visit (Day -7 to Day 0), Visit 1/Baseline Visit (Day 1), Visit 2 (Day 14) and Visit 3 (Day 28).
- Conditions
- Dry Eye Disease
- Being tested
- Propylene glycol-based eye drops
- Keywords
- mixed dry eye, aqueous-deficient dry eye, lipid-deficient dry eye, evaporative dry eye, tear film, eye drops, artificial tears, lipid layer, eye symptoms, meibomian gland dysfunction, MGD, SYSTANE, SYSTANE Complete, nanoemulsion
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propylene glycol-based eye dropsOther
Also called SYSTANE® Complete
Nano-emulsion ocular lubricant
| Study group | Role | What they receive |
|---|---|---|
| SYSTANE Complete | Experimental | Propylene glycol-based eye drops, 1 drop in each eye twice a day (BID) (morning and evening) for 28 days. Patients can administer additional doses in between the scheduled daily doses as needed Receives: Other: Propylene glycol-based eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14
TFBUT will be assessed using fluorescein, an ocular staining dye
Measured: Baseline, Day 14
Secondary outcomes (8)
Change from baseline in dry eye symptom score at Day 1
As reported by the patient using a Likert scale post drop instillation
Measured: Baseline, Day 1
Soothing sensation score
As reported by the patient using a Likert scale post drop instillation
Measured: Day 1
Tolerability assessment score
As reported by the patient using an assessment questionnaire post drop instillation
Measured: Day 1
Change from baseline in ocular discomfort at Day 14
As reported by the patient using a Visual Analogue Scale (VAS)
Measured: Baseline, Day 14
Change from baseline in corneal staining score at Day 28
Assessment of ocular staining using staining dye under a slit lamp
Measured: Baseline, Day 28
Change from baseline in response to the revised IDEEL questionnaire at Day 28
As reported by the patient using a subjective questionnaire
Measured: Baseline, Day 28
Change from baseline in EQ-5D-5L score(s) at Day 28
As reported by the patient using a validated questionnaire
Measured: Baseline, Day 28
Change from baseline in TFBUT at Day 28
TFBUT will be assessed using fluorescein, an ocular staining dye
Measured: Baseline, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start18 Jul 2018
- Primary completion30 Apr 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon Pharmaceuticals, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492541
- Sponsor's protocol ID
- CDMGD0012401
- Status last verified
- Jun 2019
- First submitted
- 3 Apr 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Efficacy and Tolerability of SYSTANE Complete in Adult Patients With Dry Eye Disease Following Topical Ocular Use for 4 Weeks: A Multicenter Trial
- ClinicalTrials.gov ID
- NCT03492541
- Acronym / sponsor ID
- CDMGD0012401
- Conditions
- Dry Eye Disease
- Keywords
- mixed dry eye, aqueous-deficient dry eye, lipid-deficient dry eye, evaporative dry eye, tear film, eye drops, artificial tears, lipid layer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
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 and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective.
Detailed description
Patients will attend 4 scheduled visits: Screening Visit (Day -7 to Day 0), Visit 1/Baseline Visit (Day 1), Visit 2 (Day 14) and Visit 3 (Day 28).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYSTANE Complete | Experimental | Other: Propylene glycol-based eye dropsPropylene glycol-based eye drops, 1 drop in each eye twice a day (BID) (morning and evening) for 28 days. Patients can administer additional doses in between the scheduled daily doses as needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have TFBUT of ≤ 5 seconds in at least one eye at Screening visit.
- Must have best corrected visual acuity (BCVA) of ≥ 20/80 (or ≥ 55 letters score or ≥ 0.6 early treatment diabetic retinopathy study (ETDRS) log of the minimum angle of resolution (LogMAR) value) in both eyes at the Screening visit.
- Must be willing to discontinue use of all artificial tear supplements and use only the study product as directed for the entire study duration.
Key exclusion criteria (3 listed)
- History of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes.
- Use of any topical ocular medication preserved with benzalkonium chloride or other products known to be toxic to the tear film lipid layer within 1 month prior to the Screening visit.
- Other protocol-specified inclusion and exclusion criteria may apply.
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-based eye dropsAlso: SYSTANE® CompleteNano-emulsion ocular lubricant | Other | SYSTANE Complete |
Primary outcome
Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14
Time frame: Baseline, Day 14
TFBUT will be assessed using fluorescein, an ocular staining dye
8 secondary outcomes
Change from baseline in dry eye symptom score at Day 1
Time frame: Baseline, Day 1
Soothing sensation score
Time frame: Day 1
Tolerability assessment score
Time frame: Day 1
Change from baseline in ocular discomfort at Day 14
Time frame: Baseline, Day 14
Change from baseline in corneal staining score at Day 28
Time frame: Baseline, Day 28
Change from baseline in response to the revised IDEEL questionnaire at Day 28
Time frame: Baseline, Day 28
Change from baseline in EQ-5D-5L score(s) at Day 28
Time frame: Baseline, Day 28
Change from baseline in TFBUT at Day 28
Time frame: Baseline, Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Alcon Pharmaceuticals study director
Alcon Research
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propylene glycol-based eye drops in people with Dry Eye Disease, run by Alcon Research at 5 sites in 3 countries.
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 3 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Spain, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Tear Film Break-up Time (TFBUT) at Day 14 (time frame: Baseline, Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2019.