Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: Systane Ultra Multidose; Drug: REFRESH PLUS®; Drug: 011516X (New Artificial Tear Formulation)

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Azusa, California, United States, 91702
      • Milton M. Hom, OD, FAAO
    • Glendale, California, United States, 91204
      • Global Research Management
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Petaluma, California, United States, 91954
      • North Bay Eye Associates, Inc.
    • San Diego, California, United States, 92123
      • Eric M. White OD Inc
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates
  • Florida
    • Crystal River, Florida, United States, 34429
      • Nature Coast Clinical Research
    • Jacksonville, Florida, United States, 32256
      • Bowden Eye & Associates
    • Miami, Florida, United States, 33176
      • Vista Health Research, LLC
    • Miami, Florida, United States, 33135
      • South Florida Research Center, Inc.
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Georgia Eye Partners
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC
  • Kansas
    • Newton, Kansas, United States, 67114
      • Alliance for Multispecialty Research, LLC
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40220
      • Senior Health Services
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Moyes Eye Center
    • Saint Charles, Missouri, United States, 63304
      • Ophthalmology Associates
  • Nevada
    • Sparks, Nevada, United States, 89431
      • Eye Care Associates of Nevada
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, PC
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Wake Forest Health Network Ophthalmology - Oak Hollow
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Eye Care Associates of Greater Cincinnati, Inc. dba Apex Eye
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Nashville, Tennessee, United States, 37205
      • Advancing Vision Research
  • Texas
    • Mission, Texas, United States, 78572
      • DCT-Shah Research, LLC dba Discovery Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Systane® Ultra Multidose; 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.	Drug: Systane Ultra Multidose; Topical eye drops; Drug: REFRESH PLUS®; Topical eye drops; Other Names: 8197X
Experimental: 011516X (New Artificial Tear Formulation); 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.	Drug: REFRESH PLUS®; Topical eye drops; Other Names: 8197X; Drug: 011516X (New Artificial Tear Formulation); Topical eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy and safety of a new artificial tear formulation in participants with signs and symptoms of DED compared with Systane Ultra MD	The change from baseline in total staining score at Day 90.The total staining score will be the sum of corneal and conjunctival staining score using modified NEI grading scale. The modified NEI/Industry Workshop guidelines will be used for grading the scale of corneal and conjunctival damage. The cornea is divided into five sectors and each of which is scored on a scale of 0-5, with a maximal total corneal staining score of 25. The conjunctiva is divided into six sectors and each of which is scored on a scale of 0-5, with a maximal total conjunctival staining score of 30.	90 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Current Symptom Survey (composite of all symptoms) at Day 90	A self-assessed 6-item visual analog scale (VAS) survey that assesses various symptoms of DED disease. The participant's response to each item will be converted to a numerical value (0 to 100).	90 Days

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Michael Robinson, MD, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: DED; Dry Eye Disease
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: 2007-301-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No