Dry Eye Disease (DED)Phase 3NCT04393441
Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease
A Phase 3 study testing 011516X (New Artificial Tear Formulation), Systane Ultra Multidose and REFRESH PLUS® in people with Dry Eye Disease (DED), run by Allergan at 26 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy and safety of a new artificial tear formulation (011516X) with Systane® Ultra Multidose for 90 days in participants 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 (DED)
- What is being tested?
- 011516X (New Artificial Tear Formulation), Systane Ultra Multidose and REFRESH PLUS®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 26 sitesUnited States
- Study dates
- 29 Jun 2020to 15 Jun 2021
- Phase
- Phase 3
- 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
- At the Screening (Day -7) and Baseline (Day 1) visits, at least 1 eye must qualify based on corneal and conjunctival staining scores
- Have used an artificial tear product for DED within 6 months of the Screening (Day -7) visit
- Have ability/agreement to continue to wear existing current spectacle correction during the study period (if applicable)
- If using any form of topical ophthalmic cyclosporine (i.e., RESTASIS®) or lifitegrast 5% ophthalmic solution (Xiidra®), participants must be using the drops for ≥90 days prior to the Screening (Day -7) visit and plan to continue without change for the duration of the study
- A female participant is eligible to participate if she is not pregnant (i.e., has a negative in-office urine pregnancy test at Screening [Day -7] and does not verbally report pregnancy at the Day 1 [Baseline] visit; is not breastfeeding, and at least 1 of the following conditions applies:
- A woman not of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance for the duration of the study
Who cannot join
- Have uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the participant at risk through participation, or which would prevent or confound protocol-specified assessments (eg, hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.)
- Participant has worn contact lenses in the last 90 days prior to the Screening (Day -7) visit and/or participant anticipates contact lens wear during the study
- Have any scheduled or planned systemic surgery or procedure during the study, which in the investigator's opinion, may impact the participant's study participation
- Presence of 1 or more of the following ocular conditions:
- Active ocular infection or non-keratoconjunctivitis sicca (KCS) ocular inflammation
- Active ocular allergy
Show all 24Show fewer
- History of recurrent herpes keratitis or active disease within 6 months prior to the Screening (Day -7) visit
- Corneal disorder or abnormality that affects corneal sensitivity or normal spreading of the tear film (except superficial punctate keratitis)
- Severe blepharitis or obvious inflammation of the lid margin, which in the judgment of the investigator, may interfere with the interpretation of the study results
- Keratoconjunctivitis sicca secondary to the destruction of conjunctival goblet cells, such as occurs with vitamin A deficiency or scarring such as that with cicatricial pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, or irradiation
- Substantial non-KCS keratitis with overlying corneal stain or other significant corneal findings not directly related to DED; in addition, participants with DED signs/symptoms (eg, filamentary keratitis) of a severity where topical monotherapy with an artificial tear would be inappropriate
- The start date of any systemic medication (including over-the-counter [OTC], herbal, prescription, or nutritional supplements) which may affect Dry Eye Disease (DED) or vision is <90 days prior to the Screening (Day -7) visit or a change in dosage is anticipated during the study.
- Systemic medications, which may affect DED or vision, include but are not limited to the following: flax seed oil, fish oil, omega-3 supplements, cyclosporine, antihistamines, cholinergic agents, anticholinergics, antimuscarinics, beta blocking agents, tricyclic antidepressants, phenothiazines, estrogen, progesterone, and other estrogen derivatives
- Have occlusion of the lacrimal puncta for either eye, with punctal plugs or cauterization < 6 months prior to the Screening (Day -7) visit or anticipated use of such procedures during the study
- Use of lid-heating therapy (i.e., LipiFlow®, iLUX®, etc.), Meibomian gland probing, or therapeutic Meibomian gland expression in either eye < 6 months prior to the Screening visit (Day -7) or anticipated use during the study
- Have history of ocular/ophthalmic surgery or trauma, which could affect corneal sensitivity and/or tear distribution (eg, cataract surgery, laser-assisted in situ keratomileusis [LASIK], photorefractive keratectomy, or any surgery involving a limbal or corneal incision) within 12 months prior to the Screening (Day -7) visit
- Are currently using topical ocular medication (OTC, herbal or prescription) or TrueTear® (intranasal neurostimulator), or have used topical ocular medication (OTC, herbal or prescription) or TrueTear within 1 month of the Screening (Day -7) visit or plan use of such treatments during the study. Exception: participants who are using the following can be considered:
- Marketed artificial tear product for the management of DED, which must be discontinued at the Screening (Day -7) visit
- Monotherapy for glaucoma or ocular hypertension (OHT) using a prostaglandin analog, beta blocker, alpha-2 agonist, or carbonic anhydrase inhibitor; any topical intraocular pressure (IOP)-lowering medications must have a start date of ≥ 90 days prior to the Screening (Day -7) visit and dosage is not expected to change during the study
- Cyclosporine topical ophthalmic preparation (eg, RESTASIS or other ophthalmic form) or lifitegrast 5% ophthalmic solution (Xiidra), with a start date of ≥ 90 days prior to the Screening (Day -7) visit and dosage is not expected to change during the study NOTE: Participants currently being treated with BOTH an IOP-lowering medication and topical ocular cyclosporine or lifitegrast cannot be enrolled.
- Are currently enrolled in an investigational drug or device study or participation in such a study within 30 days of entry into this study at the Screening (Day -7) visit
- Report an average daily artificial tear use of >6 times per day within 6 months of the Screening (Day -7) visit
- Females who are pregnant, nursing, or planning a pregnancy during the study or females who are of childbearing potential and not using a reliable method of contraception
- Have history of allergies or sensitivity to the study interventions or its components (including all REFRESH and Systane product lines) or diagnostics (eg, topical ocular anesthetic, sodium fluorescein, or lissamine green).
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Georgia Eye Partners
Atlanta, Georgia, 30342
Milton M. Hom, OD, FAAO
Azusa, California, 91702
Eye Care Associates of Greater Cincinnati, Inc. dba Apex Eye
Cincinnati, Ohio, 45236
Nature Coast Clinical Research
Crystal River, Florida, 34429
Global Research Management
Glendale, California, 91204
Wake Forest Health Network Ophthalmology - Oak Hollow
High Point, North Carolina, 27262
Bowden Eye & Associates
Jacksonville, Florida, 32256
Moyes Eye Center
Kansas City, Missouri, 64154
Senior Health Services
Louisville, Kentucky, 40220
Total Eye Care, PA
Memphis, Tennessee, 38119
South Florida Research Center, Inc.
Miami, Florida, 33135
Vista Health Research, LLC
Miami, Florida, 33176
DCT-Shah Research, LLC dba Discovery Clinical Trials
Mission, Texas, 78572
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
Advancing Vision Research
Nashville, Tennessee, 37205
Eye Research Foundation
Newport Beach, California, 92663
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114
North Bay Eye Associates, Inc.
Petaluma, California, 91954
Kannarr Eye Care, LLC
Pittsburg, Kansas, 66762
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Ophthalmology Associates
Saint Charles, Missouri, 63304
Eric M. White OD Inc
San Diego, California, 92123
Eye Care Associates of Nevada
Sparks, Nevada, 89431
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
West Bay Eye Associates
Warwick, Rhode Island, 02888
About this study
Official title: A Multicenter, Single-masked, Randomized Study to Compare the Efficacy and Safety of a New Artificial Tear Formulation (011516X) With Systane® Ultra Multidose for 90 Days in Participants With Dry Eye Disease
The purpose of this study is to compare the efficacy and safety of a new artificial tear formulation (011516X) with Systane® Ultra Multidose for 90 days in participants with Dry Eye Disease (DED).
- Conditions
- Dry Eye Disease (DED)
- Being tested
- 011516X (New Artificial Tear Formulation), Systane Ultra Multidose, REFRESH PLUS®
- Keywords
- Dry Eye Disease, DED
- 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.
011516X (New Artificial Tear Formulation)Drug
Topical eye drops
Systane Ultra MultidoseDrug
Topical eye drops
REFRESH PLUS®Drug
Also called 8197X
Topical eye drops
| Study group | Role | What they receive |
|---|---|---|
| Systane® Ultra Multidose | Active comparator | All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of Systane® Ultra Multidose in each eye 3 times daily for up to 90 days. Receives: Drug: Systane Ultra Multidose; Drug: REFRESH PLUS® |
| 011516X (New Artificial Tear Formulation) | Experimental | All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of 011516X in each eye 3 times daily for up to 90 days. Receives: Drug: 011516X (New Artificial Tear Formulation); Drug: REFRESH PLUS® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Staining Score at Day 90 in the Study Eye
The total staining score is the sum of corneal and conjunctival staining score using Modified NEI grading scale. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined total staining score is based on the sum of the five zones on the cornea and six zones on the conjunctiva. Each zone is graded on a 0 to 5 scale (0=no staining; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0 to 55. The higher the score, the worse the dry eye condition. A negative change from Baseline represents a decrease in the severity of staining (improvement). The study eye is defined as the worst eye based on total ocular staining score at Baseline (Day 1). The fellow eye is the other eye. A mixed-effects model repeated measures (MMMR) was used for analyses.
Measured: Baseline (Day 1) and Day 90
Secondary outcomes (1)
Change From Baseline in Current Symptom Survey Total Score at Day 90
The Current Symptom Survey is a self-assessed 6-item visual analog scale (VAS) survey that assesses symptoms of dry eye disease (DED) including: burning, dryness, irritation, grittiness/foreign body sensation, blurry/fluctuating vision, overall ocular pain/discomfort. Each individual symptom is rated using a score range of 0=none to 100=maximum. The total score, ranging from 0 to 600, is calculated as the sum of individual symptom scores. A negative change from Baseline indicates improvement in DED symptoms experienced by the participant. This is an overall evaluation not per eye. A MMMR model was used for analyses.
Measured: Baseline (Day 1) and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start29 Jun 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
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 Eye Disease (DED)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Robinson, MD, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393441
- Sponsor's protocol ID
- 2007-301-005
- Status last verified
- May 2024
- First submitted
- 14 May 2020
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-masked, Randomized Study to Compare the Efficacy and Safety of a New Artificial Tear Formulation (011516X) With Systane® Ultra Multidose for 90 Days in Participants With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04393441
- Acronym / sponsor ID
- 2007-301-005
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Dry Eye Disease, DED
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Posted 26 Jun 2024
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 the efficacy and safety of a new artificial tear formulation (011516X) with Systane® Ultra Multidose for 90 days in participants with Dry Eye Disease (DED).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane® Ultra Multidose | Active comparator | Drug: Systane Ultra Multidose, Drug: REFRESH PLUS®All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of Systane® Ultra Multidose in each eye 3 times daily for up to 90 days. |
| 011516X (New Artificial Tear Formulation) | Experimental | Drug: 011516X (New Artificial Tear Formulation), Drug: REFRESH PLUS®All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of 011516X in each eye 3 times daily for up to 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At the Screening (Day -7) and Baseline (Day 1) visits, at least 1 eye must qualify based on corneal and conjunctival staining scores
- Have used an artificial tear product for DED within 6 months of the Screening (Day -7) visit
- Have ability/agreement to continue to wear existing current spectacle correction during the study period (if applicable)
- If using any form of topical ophthalmic cyclosporine (i.e., RESTASIS®) or lifitegrast 5% ophthalmic solution (Xiidra®), participants must be using the drops for ≥90 days prior to the Screening (Day -7) visit and plan to continue without change for the duration of the study
- A female participant is eligible to participate if she is not pregnant (i.e., has a negative in-office urine pregnancy test at Screening [Day -7] and does not verbally report pregnancy at the Day 1 [Baseline] visit; is not breastfeeding, and at least 1 of the following conditions applies:
Key exclusion criteria (24 listed)
- Have uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the participant at risk through participation, or which would prevent or confound protocol-specified assessments (eg, hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.)
- Participant has worn contact lenses in the last 90 days prior to the Screening (Day -7) visit and/or participant anticipates contact lens wear during the study
- Have any scheduled or planned systemic surgery or procedure during the study, which in the investigator's opinion, may impact the participant's study participation
- Presence of 1 or more of the following ocular conditions:
- The start date of any systemic medication (including over-the-counter [OTC], herbal, prescription, or nutritional supplements) which may affect Dry Eye Disease (DED) or vision is <90 days prior to the Screening (Day -7) visit or a change in dosage is anticipated during 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 |
|---|---|---|
| 011516X (New Artificial Tear Formulation)Topical eye drops | Drug | 011516X (New Artificial Tear Formulation) |
| Systane Ultra MultidoseTopical eye drops | Drug | Systane® Ultra Multidose |
| REFRESH PLUS®Also: 8197XTopical eye drops | Drug | 011516X (New Artificial Tear Formulation), Systane® Ultra Multidose |
Primary outcome
Change From Baseline in Total Staining Score at Day 90 in the Study Eye
Time frame: Baseline (Day 1) and Day 90
The total staining score is the sum of corneal and conjunctival staining score using Modified NEI grading scale. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined total staining score is based on the sum of the five zones on the cornea and six zones on the conjunctiva. Each zone is graded on a 0 to 5 scale (0=no staining; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0 to 55. The higher the score, the worse the dry eye condition. A negative change from Baseline represents a decrease in the severity of staining (improvement). The study eye is defined as the worst eye based on total ocular staining score at Baseline (Day 1). The fellow eye is the other eye. A mixed-effects model repeated measures (MMMR) was used for analyses.
1 secondary outcome
Change From Baseline in Current Symptom Survey Total Score at Day 90
Time frame: Baseline (Day 1) and Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
Michael Robinson, MD study director
Allergan
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 011516X (New Artificial Tear Formulation), Systane Ultra Multidose and REFRESH PLUS® in people with Dry Eye Disease (DED), run by Allergan at 26 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 7 inclusion and 24 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2024). 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 Staining Score at Day 90 in the Study Eye (time frame: Baseline (Day 1) and Day 90). 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 26 Jun 2024.