Dry Eye Disease
Conditions
Brief summary
This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.
Interventions
DRUGAG-80308
AG-80308 Eye Drop Solution
Sponsors
ORA, Inc.
Allgenesis Biotherapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, 18 years of age or older at the screening visit 2. Diagnosis of dry eye disease in both eyes with or without meibomian gland disease
Exclusion criteria
1. Participation in any investigational study within 30 days prior to baseline or exposure to an investigational drug must be fully washed out (at least 5 half-lives) 2. Any ocular infection or inflammation within 30 days prior to the screening visit 3. Corneal disorder or abnormalities other than dry eye disease that impact normal spreading of the tear film (except superficial punctate keratitis) 4. History of chronic ocular allergy, systemic lupus erythematosus, rheumatoid arthritis, corneal ulcer/erosions, uveitis or dry eye due to Stevens Johnson syndrome, irradiation, alkali burns, cicatricial pemphigoid or vitamin A deficiency. 5. Use of contact lenses in either eye within 14 days of screening visit or planned use during the study 6. Use of the dry eye and/or meibomian gland disease medications/procedures within 2 to 8 weeks prior to the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of adverse events (AEs) and serious AEs (SAEs) | Screening to 3 months |
Other
| Measure | Time frame |
|---|---|
| Mean change from baseline in ocular surface staining | Screening to 3 months |
| Mean change from baseline in dry eye symptoms | Screening to 3 months |
| Mean change from baseline in Schirmer's test | Screening to 3 months |
Countries
United States
Outcome results
None listed