A Study of AG-80308 in Dry Eye Patients

Completed · Phase 1

Conditions studied: Dry Eye Disease

In brief

This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.

Key facts

Study ID

NCT05372107

Run by

Allgenesis Biotherapeutics Inc.

People needed

84

Starts

2022-06-13

Expected to finish

2022-11-02

Last updated by the study team

2022-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Eye Research Foundation — Newport Beach, California, United States
• Andover Eye Associates — Raynham, Massachusetts, United States
• Alpine Research Organization, Inc. — Clinton, Utah, United States

Full record on ClinicalTrials.gov

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