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
Overview
- Phase
- Phase 3
- Intervention
- Systane Ultra Multidose
- Conditions
- Dry Eye Disease (DED)
- Sponsor
- Allergan
- Enrollment
- 400
- Locations
- 26
- Primary Endpoint
- Change From Baseline in Total Staining Score at Day 90 in the Study Eye
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
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:
- •A woman not of childbearing potential (WOCBP) OR
- •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
Arms & Interventions
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.
Intervention: Systane Ultra Multidose
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.
Intervention: REFRESH PLUS®
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.
Intervention: 011516X (New Artificial Tear Formulation)
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.
Intervention: REFRESH PLUS®
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change From Baseline in Current Symptom Survey Total Score at Day 90(Baseline (Day 1) and Day 90)