Status:
COMPLETED
A Study of AG-80308 in Dry Eye Patients
Lead Sponsor:
Allgenesis Biotherapeutics Inc.
Collaborating Sponsors:
ORA, Inc.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2022
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05372107
Start Date
June 13 2022
End Date
November 2 2022
Last Update
November 29 2022
Active Locations (3)
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1
Eye Research Foundation
Newport Beach, California, United States, 92663
2
Andover Eye Associates
Raynham, Massachusetts, United States, 02767
3
Alpine Research Organization, Inc.
Clinton, Utah, United States, 84015