A Study of AG-80308 in Dry Eye Patients

Phase 1

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: AG-80308

• Registration Number: NCT05372107
• Lead Sponsor: Allgenesis Biotherapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-08
• Study First Submitted QC: 2022-05-08
• Study First Posted: 2022-05-12
• Study Start: 2022-06-13
• Status Verified: 2022-07
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	AG-80308	One drop of 0.001% AG-80308, two times daily to both eyes for 3 months
Group 2	AG-80308	One drop of 0.03% AG-80308, two times daily to both eyes for 3 months
Group 3	AG-80308	One drop of 0.1% AG-80308, two times daily to both eyes for 3 months
Group 4	AG-80308	One drop of 0.03% AG-80308, new formulation, two times daily to both eyes for 3 months

Primary Outcome Measures

Name	Time	Method
Evaluation of adverse events (AEs) and serious AEs (SAEs)	Screening to 3 months

Trial Locations

Locations (3)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Alpine Research Organization, Inc.; 🇺🇸 Clinton, Utah, United States

Andover Eye Associates; 🇺🇸 Raynham, Massachusetts, United States