NCT05372107CompletedPhase 1
A Multicenter, Double-Masked, Phase 1b Study Evaluating the Safety, Tolerability, and Dose-Response of Topical AG-80308 in Patients With Dry Eye Disease
Allgenesis Biotherapeutics Inc.3 sites in 1 country84 target enrollmentStarted: June 13, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 84
- Locations
- 3
- Primary Endpoint
- Evaluation of adverse events (AEs) and serious AEs (SAEs)
Study Overview
Brief Summary
This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, 18 years of age or older at the screening visit
- •Diagnosis of dry eye disease in both eyes with or without meibomian gland disease
Exclusion Criteria
- •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)
- •Any ocular infection or inflammation within 30 days prior to the screening visit
- •Corneal disorder or abnormalities other than dry eye disease that impact normal spreading of the tear film (except superficial punctate keratitis)
- •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.
- •Use of contact lenses in either eye within 14 days of screening visit or planned use during the study
- •Use of the dry eye and/or meibomian gland disease medications/procedures within 2 to 8 weeks prior to the screening visit
Arms & Interventions
Group 1
Experimental
One drop of 0.001% AG-80308, two times daily to both eyes for 3 months
Intervention: AG-80308 (Drug)
Group 2
Experimental
One drop of 0.03% AG-80308, two times daily to both eyes for 3 months
Intervention: AG-80308 (Drug)
Group 3
Experimental
One drop of 0.1% AG-80308, two times daily to both eyes for 3 months
Intervention: AG-80308 (Drug)
Group 4
Experimental
One drop of 0.03% AG-80308, new formulation, two times daily to both eyes for 3 months
Intervention: AG-80308 (Drug)
Outcomes
Primary Outcomes
Evaluation of adverse events (AEs) and serious AEs (SAEs)
Time Frame: Screening to 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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