Dry Eye Disease
Conditions
Keywords
Dry Eye Disease, ABBV-444
Brief summary
Dry Eye Disease (DED) refers to a long-term condition that happens when there is not enough lubrication in your eyes. This can happen when your eye cannot make enough tears or if you make poor-quality tears. The purpose of this study is to compare the efficacy and safety of a new artificial tear formulation (ABBV-444) with Refresh Optive UD for 90 days in participants with Dry Eye Disease (DED. ABBV-444 is being developed for the treatment of Dry Eye Disease (DED). Participants will be placed into 1 of 2 treatment arms. Each group receives different treatment. Adult participants diagnosed with dry eye disease will be enrolled. Around 250 participants will be enrolled in the study at approximately 20 sites across the US In this study, participants first complete a 7-day run-in period using REFRESH PLUS® eye drops. Those eligible are then randomized to receive ABBV-444 eye drops or REFRESH OPTIVE® Unit Dose eye drops. Participants in both arms will receive treatment for a 90-day treatment period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend multiple required study visits during the study at the study site. The effect of the treatment will be checked by medical assessments and questionnaires.
Interventions
DRUGABBV-444
Topical eye drop
DRUGREFRESH OPTIVE UD
Topical eye drop
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ocular Surface Disease Index (OSDI) score of ≥ 28 and ≤ 65 (based upon a 0 to 100 scale) at Screening. (Day -7) and an OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Baseline (Day 1). * Three consecutive tear breakup time (TBUT) tests of ≤ 10 seconds in at least 1 eye at both the Screening (Day -7) and Baseline (Day 1) Visits. * Grade 1 to 4 (modified National Eye Institute \[NEI\] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that is related to dry eye in at least 1 eye at both Screening (Day -7) and Baseline (Day 1). * Have used an artificial tear product for dry eye disease (DED) within 6 months of Screening (Day -7) Visit.
Exclusion criteria
* Participant has uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the subject at risk through participation, or which would prevent or confound protocol-specified assessments (e.g., 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. * Any scheduled or planned systemic surgery or procedure during the study, which in the investigator's opinion, may impact the participant's study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Ocular Surface Disease Index (OSDI) Score | Baseline to Day 90 | The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5- point scale (0=none of the time to 4=all of the time), with higher scores representing worse symptoms. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no symptom to 100=worst symptom). A negative number change from baseline represents an improvement. |
| Number of Participants with Adverse Events (AEs) | Baseline to Day 90 | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Total Ocular Surface Staining Score (OS Staining) (modified NEI Grid, with fluorescein for cornea; and lissamine green for conjunctiva) | Baseline to Day 90 | Corneal staining will be evaluated in each eye at all visits and will be graded 2 minutes after instillation of the fluorescein, during which time TBUT is measured. Grade staining independently approximately 3 minutes in the 5 zones of the cornea (1 through 5) as shown below based upon a 6-point scale (0, 1, 2, 3, 4, 5) for a maximum grade of 5 in each of the 5 zones (or a total maximal score of 25 for each eye). |
| Change from Baseline in Tear Breakup Time (TBUT) with Fluorescein | Baseline to Day 90 | The TBUT will be determined during the approximately 3 minutes wait for corneal staining using fluorescein strips moistened with saline drops applied to the treatment area. Participants will be asked to blink normally 2 to 3 times to evenly spread the fluorescein. Then, they will be asked to not blink for as long as they can. As soon as they start holding the blink, the timing with the stopwatch will begin. The stopwatch is stopped on the first occurrence of true tear break-up, not just local thinning or tear film irregularity |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed