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

NCT04393441 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2007-301-005
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 26

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).

Conditions

Dry Eye Disease (DED)

Keywords

Dry Eye Disease; DED

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 1) and Day 90

Secondary Outcomes (1)

• Change From Baseline in Current Symptom Survey Total Score at Day 90

  Baseline (Day 1) and Day 90

Study Arms (2)

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.

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.

Drug: 011516X (New Artificial Tear Formulation); Drug: REFRESH PLUS®

Interventions

011516X (New Artificial Tear Formulation) DRUG

Topical eye drops

011516X (New Artificial Tear Formulation)

Systane Ultra Multidose DRUG

Topical eye drops

Systane® Ultra Multidose

REFRESH PLUS® DRUG

Topical eye drops

Also known as: 8197X

011516X (New Artificial Tear Formulation); Systane® Ultra Multidose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (26)

Milton M. Hom, OD, FAAO

Azusa, California, 91702, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

North Bay Eye Associates, Inc.

Petaluma, California, 91954, United States

Location

Eric M. White OD Inc

San Diego, California, 92123, United States

Location

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Nature Coast Clinical Research

Crystal River, Florida, 34429, United States

Location

Bowden Eye & Associates

Jacksonville, Florida, 32256, United States

Location

South Florida Research Center, Inc.

Miami, Florida, 33135, United States

Location

Vista Health Research, LLC

Miami, Florida, 33176, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Georgia Eye Partners

Atlanta, Georgia, 30342, United States

Location

Clayton Eye Clinical Research, LLC

Morrow, Georgia, 30260, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Kannarr Eye Care, LLC

Pittsburg, Kansas, 66762, United States

Location

Senior Health Services

Louisville, Kentucky, 40220, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Ophthalmology Associates

Saint Charles, Missouri, 63304, United States

Location

Eye Care Associates of Nevada

Sparks, Nevada, 89431, United States

Location

Rochester Ophthalmological Group, PC

Rochester, New York, 14618, United States

Location

Wake Forest Health Network Ophthalmology - Oak Hollow

High Point, North Carolina, 27262, United States

Location

Eye Care Associates of Greater Cincinnati, Inc. dba Apex Eye

Cincinnati, Ohio, 45236, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research

Nashville, Tennessee, 37205, United States

Location

DCT-Shah Research, LLC dba Discovery Clinical Trials

Mission, Texas, 78572, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Michael Robinson, MD

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: June 29, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• 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.

Locations

US (26)