Dry Eye DiseaseNCT05056155
Systane Complete Multi-symptom Relief
A study testing Systane Complete in people with Dry Eye Disease, run by Alcon Research at 4 sites in United States.
Trial summary
The purpose of this study is to demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED). 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?
- Systane Complete
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Nov 2021to 25 Mar 2022
- 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
- Able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
- Willing and able to attend all study visits as required per protocol.
- Have dry eye symptoms as specified in the protocol.
- Willing to discontinue use of all habitual artificial tear supplements for the entire study duration.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Ocular conditions as specified in the protocol.
- Contact lens use within one week prior to screening visit.
- Use of medications as specified in the protocol.
- Pregnant or breast feeding.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alcon Investigator 8175
Austin, Texas, 78731
Alcon Investigator 8046
Granville, Ohio, 43023
Alcon Investigator 1455
Kansas City, Missouri, 64111
Alcon Investigator 6313
Powell, Ohio, 43065
About this study
The purpose of this study is to demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED).
Read the detailed description
Subjects will be expected to attend a screening/baseline visit and one additional visit at Day 28 (± 2 days), with a telephone call visit conducted at Day 14 (± 2 days). Individual duration of subject participation will be approximately 28 days.
- Conditions
- Dry Eye Disease
- Being tested
- Systane Complete
- Keywords
- 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 CompleteOther
Also called Systane® Complete Lubricant Eye Drops
Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film
| Study group | Role | What they receive |
|---|---|---|
| Systane Complete | Experimental | First dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days Receives: Other: Systane Complete |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline at Day 28 in IDEEL-SB Question "Sore"
The Impact of Dry Eye on Everyday Life - Symptoms Bother (IDEEL-SB) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Sore Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Measured: Baseline (Day 0), Day 28
Change from Baseline at Day 28 in IDEEL-SB Question "Stinging"
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Stinging Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Measured: Baseline (Day 0), Day 28
Change from Baseline at Day 28 in IDEEL-SB Question "Burning"
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Burning Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Measured: Baseline (Day 0), Day 28
Change from Baseline at Day 28 in IDEEL-SB Question "Tired Eyes"
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Tired Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Measured: Baseline (Day 0), Day 28
Change from Baseline at Day 28 in DEQ-5 Question "Watery"
The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, "During a typical day in the past month, how often did your eyes look or feel excessively watery?" using a 0-4 Likert-type scale, where 0 = Never and 4 = Constantly. A negative change value will represent perceived improvement.
Measured: Baseline (Day 0), Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start9 Nov 2021
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Ocular Health, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056155
- Sponsor's protocol ID
- DEC262-P002
- Status last verified
- Mar 2022
- First submitted
- 15 Sep 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bickle K, Miller JR, Tauber J, Awisi-Gyau D. Multi-symptom Relief with Propylene Glycol-Hydroxypropyl-Guar Nanoemulsion Lubricant Eye Drops in Subjects with Dry Eye Disease: A Post-Marketing Prospective Study. Ophthalmol Ther. 2024 Feb;13(2):481-494. doi: 10.1007/s40123-023-00853-3. Epub 2023 Dec 11.
PubMed 38079084
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systane Complete Multi-symptom Relief
- ClinicalTrials.gov ID
- NCT05056155
- Acronym / sponsor ID
- DEC262-P002
- Conditions
- Dry Eye Disease
- Keywords
- Eye drops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 24 Sep 2021 (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 demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED).
Detailed description
Subjects will be expected to attend a screening/baseline visit and one additional visit at Day 28 (± 2 days), with a telephone call visit conducted at Day 14 (± 2 days). Individual duration of subject participation will be approximately 28 days.
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: Systane CompleteFirst dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
- Willing and able to attend all study visits as required per protocol.
- Have dry eye symptoms as specified in the protocol.
- Willing to discontinue use of all habitual artificial tear supplements for the entire study duration.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Ocular conditions as specified in the protocol.
- Contact lens use within one week prior to screening visit.
- Use of medications as specified in the protocol.
- Pregnant or breast feeding.
- Other protocol-defined 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 |
|---|---|---|
| Systane CompleteAlso: Systane® Complete Lubricant Eye DropsPropylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film | Other | Systane Complete |
Primary outcome
Change from Baseline at Day 28 in IDEEL-SB Question "Sore"
Time frame: Baseline (Day 0), Day 28
The Impact of Dry Eye on Everyday Life - Symptoms Bother (IDEEL-SB) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Sore Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in IDEEL-SB Question "Stinging"
Time frame: Baseline (Day 0), Day 28
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Stinging Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in IDEEL-SB Question "Burning"
Time frame: Baseline (Day 0), Day 28
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Burning Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in IDEEL-SB Question "Tired Eyes"
Time frame: Baseline (Day 0), Day 28
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Tired Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in DEQ-5 Question "Watery"
Time frame: Baseline (Day 0), Day 28
The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, "During a typical day in the past month, how often did your eyes look or feel excessively watery?" using a 0-4 Likert-type scale, where 0 = Never and 4 = Constantly. A negative change value will represent perceived improvement.
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 29 Mar 2022.
- Derived from this study: PubMed 38079084Bickle K, Miller JR, Tauber J, Awisi-Gyau D. Multi-symptom Relief with Propylene Glycol-Hydroxypropyl-Guar Nanoemulsion Lubricant Eye Drops in Subjects with Dry Eye Disease: A Post-Marketing Prospective Study. Ophthalmol Ther. 2024 Feb;13(2):481-494. doi: 10.1007/s40123-023-00853-3. Epub 2023 Dec 11.
- Individual participant dataSharing planned: No
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Dry Eye
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.
Clinical Trial Lead, Ocular Health study director
Alcon Research, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane Complete in people with Dry Eye Disease, run by Alcon Research at 4 sites in United States.
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 5 inclusion and 5 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 at Day 28 in IDEEL-SB Question "Sore" (time frame: Baseline (Day 0), Day 28). The study lists 5 primary outcomes in all. 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 NCT05056155, which also lists 1 linked publication.
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 Mar 2022.