Clinical trial NCT04393441: Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease (DED)
Keywords: Dry Eye Disease
DED
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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:

  1. A woman not of childbearing potential (WOCBP) OR
  2. A WOCBP who agrees to follow the contraceptive guidance for the duration of the study

Exclusion Criteria:

* 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
  * 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).

Primary outcomes:
measure: Change From Baseline in Total Staining Score at Day 90 in the Study Eye
timeFrame: Baseline (Day 1) and Day 90
Secondary outcomes:
measure: Change From Baseline in Current Symptom Survey Total Score at Day 90
timeFrame: Baseline (Day 1) and Day 90
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Milton M. Hom, OD, FAAO
state: California
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: San Diego
country: United States
facility: Eric M. White OD Inc
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Crystal River
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Bowden Eye & Associates
state: Florida
city: Miami
country: United States
facility: South Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Vista Health Research, LLC
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Atlanta
country: United States
facility: Georgia Eye Partners
state: Georgia
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Pittsburg
country: United States
facility: Kannarr Eye Care, LLC
state: Kansas
city: Louisville
country: United States
facility: Senior Health Services
state: Kentucky
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Saint Charles
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Sparks
country: United States
facility: Eye Care Associates of Nevada
state: Nevada
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: High Point
country: United States
facility: Wake Forest Health Network Ophthalmology - Oak Hollow
state: North Carolina
city: Cincinnati
country: United States
facility: Eye Care Associates of Greater Cincinnati, Inc. dba Apex Eye
state: Ohio
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Nashville
country: United States
facility: Advancing Vision Research
state: Tennessee
city: Mission
country: United States
facility: DCT-Shah Research, LLC dba Discovery Clinical Trials
state: Texas
Study officials:
affiliation: Allergan
name: Michael Robinson, MD
role: STUDY_DIRECTOR
References: